27 Regulatory Affairs Specialist jobs in Saudi Arabia

At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you’ll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our patients and customers. We foster an inclusive culture and are looking for diverse, talented people to join Alcon.
- As a Regulatory Affairs Specialist, you will facilitate the internal and external regulatory activities of Alcon portfolio with objective of smoothly registering / re-registering and maintaining Alcon products in compliance with the local legislations and business needs. Additionally, you will support business in Saudi Arabia through providing accurate regulatory information in a timely fashion to the different functions, whilst adhering to best practice principles and Alcon standard operational procedures, acting as a link between the organization, the distributors and the regulatory authorities wherever possible to ensure registration and supply in compliance with appropriate local legislation. In this role, a typical day will include:
Develop and maintain a product database of all Alcon portfolio and their status in Saudi Arabia- Maintain an up-to-date local regulatory archive for Alcon products and regulations (corporate dossier, submitted documents, registration certificates, etc.)
- Act as point of contact to receive and compile regional Regulatory surveys for Saudi Arabia to be reviewed by the Regulatory Affairs Manager
- Secure fast registration, renewal and variation submission and approvals of Alcon products in Saudi Arabia
- Secure fast submission of internally approved promotional materials through local distributors
- Pre-align with the Regulatory Affairs Manager/Director on the needed action and priority for each product based on local market /RA needs & corporate strategy and Regional Specificities.
- Support the Regulatory Affairs Manager/ Director to set proper product launch plans by proactively communicating and sharing registration status, packaging material approvals and or any challenges due to change in regulations.
- Maintain good relationships with local authorities and associations, where applicable.
- Assists in the Arabic-to-English and English-to-Arabic translation of product information and checks for translation accuracy in the product packaging and product package inserts/label/ Instruction for Use
- Perform in accordance with Alcon’s Patient Safety and Quality Management Guidelines

WHAT YOU’LL BRING TO ALCON:
Bachelor’s degree in biomedical Engineer or Science related degree-
- Fluent English and Arabic (written and spoken)-
- Saudi nationality-
- Minimum 3 years’ experience in a Regulatory Affairs position in Saudi Arabia in a multinational Medical Company-
- Extensive knowledge of Regulatory Affairs environment (processes, organization, legislation,) in Saudi Arabia-
- Highly organized with a keen sense of what it takes to get the job done; strong operating skills and a sense of urgency.-
- Must have strong collaboration skills, the ability to work in a matrix organization and experience working in a partnership environment, and excellent in influencing others without direct hierarchic link.-
- Strong mental agility, motivation and high commitment are required to deal with the variety of therapeutic & diagnostic indications, product segments and market access strategies. Strong interpersonal skills are mandatory for this position; communication, business and customer-oriented approach.-
- Ability to build and influence external contact.HOW YOU CAN THRIVE AT ALCON:
Competitive salary-
- Comprehensive benefits package-
- Training and continuous development; Be part of a high performing leader in ophthalmology company with a lot of opportunities to further develop your professional career.-
- International exposure-
- Open, friendly and collaborative culture; Work in a challenging environment with an outstanding team that will support him/her to achieve goals and performance.Alcon Careers

Overview

Regulatory Affairs Specialist - KSA

Company: Servier

Location: Riyadh, Saudi Arabia

Type: Full-time Employment / Unlimited

Date posted: Sep 10, 2025

Role Responsibilities

• Life-Cycle management of products
• Pre-registration coordination with WRA and preparation of documentation for KSA to compile product and manufacturing site files, review/preparation/submission of dossiers, fees, inquiries, answers to questions, approvals
• Life-cycle management of products including new registrations, renewals/minor variations of products and sites
• Follow country-specific procedures and SFDA guidelines in the KSA market
• Coordination and liaison with WRA teams/distributors for preparation of all types of regulatory dossiers and local documentation
• Preparation of price forms and related documentation for new product registration files
• Liaising with WRA, agents and authorities for documentation submission and follow-up
• Monitor the registration status of products (submission, registration, expiry dates)

• Closely collaborate with the Head of the Department for all regulatory tasks
• Monthly Reports, Correspondences/Mails, Scientific Office Renewal at the SFDA
• Active involvement in budget preparation for KSA Regulatory Affairs
• Follow-up on regulatory guidelines and sharing regulatory information with all concerned
• Reference standard submissions to the authorities
• Assist the Supply Chain Department with tenders – preparation of documentation for institutional tender submissions
• Actively involved in Regulatory Audits

• Regulatory Site Management: For all activities related to KSA - WRA Portal, Ereca, Solaris, LSRIMS, Cosac

• Other Related Tasks: Managing/organizing department-supported conferences for Health Authorities in the ME, liaising with agents and Health Authorities in KSA, responsible for Change Controls for Variations in the ME region, deputy for local responsible person for advertisement/promotional material, deputy for validation of packaging items, cross-collaboration with other ME departments

• Dimensions: Geographical span ME - KSA; work with ME Regulatory Lead to understand regulatory guidelines and technical requirements in KSA; life cycle management and compliance; cross-functional support; report to Head of Department

Requirements

• Educational qualifications : Bachelor’s Degree in Pharmacy / Science
• Relevant Experience : 3+ years of relevant pharmaceutical regulatory experience within a large multinational organization; experience in Saudi Arabia preferred; experience in a Global pharmaceutical company is advantageous

• Skills & Personal Characteristics : Good knowledge of the Regulatory environment and procedures in KSA; strong regulatory intelligence; ability to work cross-functionally; strategic thinker, innovative, able to drive multiple initiatives; ability to work under pressure; team player; multitasking, organized, process- and result-oriented; excellent interpersonal, negotiation and relationship-building skills; excellent communication and digital skills; fluent in English and Arabic (French is an added advantage)

We’re committed to therapeutic progress to serve patient needs. We put the diversity of our employees as a source of richness for the fulfillment of this vocation. Tailor-made onboarding journeys, mobility opportunities, quality trainings, responsible management, team spirit — all focused on your well-being.

At Servier, we are dedicated to advancing therapeutic progress to serve patient needs.

EEO statement: We are an equal opportunity employer. Referrals increase your chances of interviewing at Servier by 2x.

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Regulatory Affairs Specialist - KSA

.

Job Purpose

• The Regulatory Affairs Specialist focuses on ensuring that the organization meets all of the applicable regulations. Their goal is to ensure that new products meet certain requirements as set by Health Authorities.
• Regulatory Affairs Specialist ME is responsible for Saudi Arabia activities (KSA).
• Identifying all elements and actions necessary for registering and maintaining valid marketing authorizations in KSA.
• Collaboration with the local partners, local authorities and WRA in France.
• Coordinate and document internal regulatory processes, such as internal audits, inspections, license renewals or registrations.
• Handle registrations of new products/sites/medical devices, pricing as well as maintaining life cycle of products in KSA, including renewals and variations.
• Ensure that all relevant regulations are fully met in dossiers, with the aim of complying with the requirements established by Health Authorities.
• Collaborates closely with the Department Head in all department related tasks and activities.
• Compile and prepare new products and manufacturing sites registration files for submissions to authorities in KSA as per Regulatory timelines.
• Cross functionality & collaboration with Global teams as well as all ME departments, provide regulatory support and guidance whenever required.

Role Responsibilities Life-Cycle management of products

• Pre-registration coordination with WRA and preparation of documentation for KSA to compile the product and manufacturing site files, Review/ Preparation/Submission of dossiers, fees, inquiries, answers to questions, approvals.
• Life-cycle management of products that includes new registrations, renewals/minor variation of both products and sites.
• Follow country specific procedures and SFDA guidelines in the KSA market.
• Coordination & liaising with WRA teams/distributors for preparation of all types of regulatory dossiers & local documentation.
• Preparation of price forms and related documentation for new product registration files.
• Liaising with WRA, agents and authorities for documentation submission and follow-up and keep track.
• To keep track of the registration status of products with submission, registration, expiry dates.

Regulatory Tasks

• Closely collaborate with the Head of the Department for all regulatory tasks.
• Monthly Reports, Correspondences/Mails, Scientific Office Renewal at the SFDA.
• Involved actively in the budget preparation of KSA Regulatory Affairs.
• Follow-up on regulatory guidelines and ensure sharing of regulatory information with all concerned.
• Reference standard submissions to the authorities.
• Helping the Supply Chain Department for tenders - preparation of documentation for institutional tender submissions.
• Actively involved in Regulatory Audits.

Regulatory Site Management

• For all activities related to KSA -WRA Portal, Ereca, Solaris, LSRIMS, Cosac.

Other related tasks

• Management/Organizing department supported conferences for Health Authorities in the ME countries.
• Liaise closely with agent and Health Authorities in KSA.
• Responsible for Change Controls for Variations for the ME region.
• Work as a deputy for the local responsible person for advertisement/promotional material.
• Deputy Local Responsible person for validation of Packaging Items.
• Cross collaboration with other ME departments.

Dimensions

• Geographical span: ME - KSA.
• Work with the ME Regulatory Lead to develop a detailed understanding of regulatory guidelines and technical requirements in KSA.
• Life cycle management of products, understanding of industry-specific regulations, audit procedures, and the ability to ensure compliance with regulatory standards.
• Work and support the KSA Regulatory Affairs team.
• Cross-functionality with other departments.
• Report to the Head of the Department.

Requirements

• Bachelor’s Degree in Pharmacy / Science.
• 3+ years of relevant pharmaceutical regulatory experience within a large multinational organization.
• Experience working in Saudi Arabia (preferred).
• Experience of working within a Global pharmaceutical company would be an advantage.

Skills & Personal characteristics

• Good knowledge of the Regulatory environment and procedures in KSA.
• Ability to work cross functional to resolve complex issues.
• Strategic thinker, innovative, able to drive multiple-simultaneous initiatives, able to work under pressure, team player.
• Multi-tasking, organized, Process & Result oriented, Focused, Problem solving, good judgment and decision-making capability.
• Excellent interpersonal, Negotiation and relationship building skills.
• Written and spoken fluency in English & Arabic (French is an added advantage).

Whatever your area of expertise, your work within the Servier Group helps advance therapeutic progress for the benefit of patients. You will be part of teams recognized for their scientific excellence and reach your full potential in a professional environment that encourages you to develop yourself. Tailor-made onboarding journeys, mobility opportunities, quality trainings, responsible management, team spirit. All this and more in a workplace focused on your well-being.

At Servier, we are committed to therapeutic progress to serve patient needs. We put the diversity of our employees as a source of richness for the fulfillment of this vocation.

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Regulatory Affairs Specialist KSA Galderma

RA Specialist will fulfill the local regulatory activities to maintain & keep the RA portfolio compliant for KSA ( 70 % ) and rest of ME markets ( 30%) . He / she will support RA manager on operational RA submissions to allow the RA managers in UAE & KSA to focus on critical projects Relfydess & Nemluvio . In addition , RA manager in KSA needs to focus on enhancing external engagement with Health authority & local trade association that is identified as a major gap currently. RA Specialist will ensure business continuity and serve as a back up for RA manager in KSA for RA in addition to serving as a back up for QA & PV , considering that RA , QA & PV are mandatory functions to be always available on site .Provide strategic and operational RA support for Saudi to ensure on time renewal, maintenance , variations of existing & new products for IA, TD, DS including mandatory regulatory. It is critical to maintain momentum to ensure compliance to constantly evolving SFDA guidelines

Duties & Responsibilities

Manage the entire registration process in ensuring approvals of new products and amendments to products

Develop and execute registration strategy in close partnership with Global RA & local RA manager

Stay abreast of - and ensure compliance with - the continuously evolving (complex & country specific) regulatory framework in KSA & rest of ME markets

Ensure compliance with, and maintenance of, existing product licenses.

Ensure high quality and timely submissions, support in enhancing regulatory intelligence , create & maintain database for simplifying local RA processes of record retention , regulatory submission tracking

Ensure that progress of applications and changes to registered details are communicated to local and global stakeholders, as appropriate

Manage in-house regulatory files, documentation and Corporate electronic databases. With the LE set up in Saudi the responsibilities & accountability of RA manager in front of Saudi HA ( SFDA ) have increased requiring more time & focus from RA manager to engage with external stakeholders & ensure compliance at all time for all regulated TD,IA,DS portfolio. RA specialist is critical to ensure compliance to ongoing RA activities , serve as back up for RA / QA/PV and allow RA to focus on critical submissions ongoing & to be made for Relfydess & Nemluvio to enable timely registrations . RA specialist will also support projects that need improvement in process enhancement & simplification tools for all ME markets , such as tracking tools , data management & also internalize some of the RA activities that are currently outsourced such as eCTD preparation in a phased manner

Saudi Arabia national and MOH licensed pharmacist

Minimum 4-5 years experience in a similar Regulatory affairs role in the field of prescription medicinal products and medical devices in Saudi Arabia & UAE

In-depth understanding of the pharmaceutical industry within Saudi Arabia, and strong connections with SFDA will be preferred

Quality experience & fair knowledge of Pharmacovigilance preferred.

Computer literate, familiar with Computer based information systems, and new

Electronic documentation systems.

Fluency in written and verbal English and Arabic

What we offer in return

You will be working for an organization that embraces diversity & inclusion and believe we will deliver better outcomes by reflecting the perspectives of our diverse customer base.

You will receive a competitive compensation package with bonus structure and extended benefit package.

You will be joining a growing company that believes in ownership from day one where everyone is empowered to grow and to take accountability.

Next Step

Please apply with an English language CV.

If your profile is a match, we will invite you for a first virtual conversation with the recruiter.

The next step is a virtual conversation with the hiring manager.

The final step is a panel conversation with the extended team.

Company Industry

• Pharma
• Biotech
• Clinical Research

Department / Functional Area

• Administration

Keywords

• Regulatory Affairs Specialist KSA

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People Looking for Regulatory Affairs Specialist KSA Jobs also searched #J-18808-Ljbffr

Regulatory Affairs Specialist - KSA

.

Job Purpose

• The Regulatory Affairs Specialist focuses on ensuring that the organization meets all of the applicable regulations. Their goal is to ensure that new products meet certain requirements as set by Health Authorities.
• Regulatory Affairs Specialist ME is responsible for Saudi Arabia activities (KSA).
• Identifying all elements and actions necessary for registering and maintaining valid marketing authorizations in KSA.
• Collaboration with the local partners, local authorities and WRA in France.
• Coordinate and document internal regulatory processes, such as internal audits, inspections, license renewals or registrations.
• Handle registrations of new products/sites/medical devices, pricing as well as maintaining life cycle of products in KSA, including renewals and variations.
• Ensure that all relevant regulations are fully met in dossiers, with the aim of complying with the requirements established by Health Authorities.
• Collaborates closely with the Department Head in all department related tasks and activities.
• Compile and prepare new products and manufacturing sites registration files for submissions to authorities in KSA as per Regulatory timelines.
• Cross functionality & collaboration with Global teams as well as all ME departments, provide regulatory support and guidance whenever required.

Role Responsibilities Life-Cycle management of products

• Pre-registration coordination with WRA and preparation of documentation for KSA to compile the product and manufacturing site files, Review/ Preparation/Submission of dossiers, fees, inquiries, answers to questions, approvals
• Life-cycle management of products that includes new registrations, renewals/minor variation of both products and sites.
• Follow country specific procedures and SFDA guidelines in the KSA market.
• Coordination & liaising with WRA teams/distributors for preparation of all types of regulatory dossiers & local documentation.
• Preparation of price forms and related documentation for new product registration files.
• Liaising with WRA, agents and authorities for documentation submission and follow-up and keep track.
• To keep track of the registration status of products with submission, registration, expiry dates.

Regulatory Tasks

• Closely collaborate with the Head of the Department for all regulatory tasks.
• Monthly Reports, Correspondences/Mails, Scientific Office Renewal at the SFDA.
• Involved actively in the budget preparation of KSA Regulatory Affairs.
• Follow-up on regulatory guidelines and ensure sharing of regulatory information with all concerned.
• Reference standard submissions to the authorities.
• Helping the Supply Chain Department for tenders - preparation of documentation for institutional tender submissions.
• Actively involved in Regulatory Audits.

Regulatory Site Management

• For all activities related to KSA -WRA Portal, Ereca, Solaris, LSRIMS, Cosac.

Other related tasks

• Management/Organizing department supported conferences for Health Authorities in the ME countries.
• Liaise closely with agent and Health Authorities in KSA.
• Responsible for Change Controls for Variations for the ME region.
• Work as a deputy for the local responsible person for advertisement/promotional material.
• Deputy Local Responsible person for validation of Packaging Items.
• Cross collaboration with other ME departments.

Dimensions

• Geographical span: ME - KSA.
• Work with the ME Regulatory Lead to develop a detailed understanding of regulatory guidelines and technical requirements in KSA.
• Life cycle management of products, understanding of industry-specific regulations, audit procedures, and the ability to ensure compliance with regulatory standards.
• Work and support the KSA Regulatory Affairs team.
• Cross-functionality with other departments.
• Report to the Head of the Department.

Requirements

• Bachelor's Degree in Pharmacy / Science.
• 3+ years of relevant pharmaceutical regulatory experience within a large multinational organization.
• Experience working in Saudi Arabia (preferred).
• Experience of working within a Global pharmaceutical company would be an advantage.

Skills & Personal characteristics

• Good knowledge of the Regulatory environment and procedures in KSA.
• Ability to work cross functional to resolve complex issues.
• Strategic thinker, innovative, able to drive multiple-simultaneous initiatives, able to work under pressure, team player.
• Multi-tasking, organized, Process & Result oriented, Focused, Problem solving, good judgment and decision-making capability.
• Excellent interpersonal, Negotiation and relationship building skills.
• Written and spoken fluency in English & Arabic (French is an added advantage).

Whatever your area of expertise, your work within the Servier Group helps advance therapeutic progress for the benefit of patients. You will be part of teams recognized for their scientific excellence and reach your full potential in a professional environment that encourages you to develop yourself. Tailor-made onboarding journeys, mobility opportunities, quality trainings, responsible management, team spirit All this and more in a workplace focused on your well-being.

At Servier, we are committed to therapeutic progress to serve patient needs. We put the diversity of our employees as a source of richness for the fulfillment of this vocation.

**In this role, the associate**:

- Identify information sources and resources for local regulations.
- Serve as RA lead on global Market Expansion registrations for simple to medium complicated projects for initial product approvals and renewals, for assays, instruments or software, in global regions outside US and EU to ensure OTD product launches.
- Be responsible for OTD of RA deliverables to meet registration plan.
- Be responsible for providing data for relevant metrics and KPI bowlers.
- Collect and coordinate information on regulatory requirements for in vitro diagnostic devices, quality, preclinical and clinical data to meet applicable regulations.
- Use best practices and knowledge of internal or external business issues to improve products or service.
- Ensure proper filing and organization of all documents and correspondence in support of and concerning all regulatory submissions.
- Interact through written and verbal correspondence and negotiate with regulatory agencies during the strategy development and pre-submission process, as appropriate for the region.
- Negotiates and consults as needed with regulatory agencies prior to in-country studies or submissions.
- Author and prepare regulatory submission, renewal, and change submission and ensure filings are in compliance with international regulations and guidelines.
- Use knowledge of regulations and develops regulatory strategy for introducing new products to global regions to meet business priorities.
- Identify RA project deliverables and contributes to development of registration schedule.
- Prepare formal written reports, PowerPoint presentations to communicate regulatory strategies and status.
- Interact with regulatory authority/ health agencies to address queries during review.
- Actively manage and monitor submissions under review. Respond promptly and negotiate with regulatory authorities, as needed.
- Provide regulatory guidance with regard to preparation, review and approval of product labeling and promotional materials to comply with country specific requirements, as needed.
- Interact cross-functionally to generate protocols and reports that require in-country testing data for registration purposes.
- Authors and prepares regulatory registration plan based on business priority.
- Have a good relationship with regional regulatory leaders and peers to expedite approval of pending registrations.
- Maintain a "focused urgency" throughout the submission process.
- Solve complex problems; by taking a new perspective using existing solutions.
- Provide training and coordinate with department personnel from regulatory, quality, and manufacturing sites, Sales, and Marketing.
- Work independently, receiving mínimal guidance and act as a resource for colleagues with less experience.
- Provide regional regulatory requirements to NPD core team via RA Lead, as needed.
- Identify product classification based on region and intended use.
- Attend and present escalations to Regulatory Steering Committee (RSC) to enable rapid approvals and renewals of products across all global regions.
- Serve as primary contact with the regulatory agency for the registration submission under review.
- Provide proactive regulatory intelligence in areas of a competitive nature and also keep abreast of changes in agency regulations and requirements is assigned regions.
- Be responsible for regulatory project timelines and management of multiple, concurrent regulatory submissions.
- Track, manage and report to leadership on regulatory review timelines.

**The essential requirements of the job include**:

- Excellent organizational skills with attention to detail and accuracy.
- Ability to work independently in a fast-paced environment with flexibility to manage changing priorities.
- Able to demonstrate a broad experience of manufacturing processes and equipment.
- Able to confidently deal with ambiguous issues and take action towards suitable solutions.
- Demonstrated excellence in communicating and presenting complex information to technical and non-technical partners.
- Proven ability to manage and prioritize multiple projects. Highly motivated, takes initiative, follow through, and complete projects in a professional and timely manner.
- IVD product experience is highly preferred.
- Prior knowledge of different databases like SAP, Sales Force, Tarius, Trackwise etc. including Agile documentation system is a bonus.
- Understands complex Regulatory Affairs concepts and should be experienced with regulations/guidelines governing development of diagnostic products.
- Excellent oral and written communication and presentation skills. Proficient in Microsoft Word, Excel, PowerPoint, Outlook, and Adobe Acrobat.
- Have conceptual and practical expertise in own discipline and basic knowledge of related disciplines.
- Have knowledge of best practices and how own area integrates with others; is aware of the competition and the factors that differentiate them in the market.

Regulatory Affairs Executive/Specialist - (562)

Zahrawi Group is a leading company in the GCC Healthcare Industry with its presence in UAE, KSA, Qatar, Bahrain, & Oman markets. The company supplies and distributes high-quality products and services to Hospitals, Clinics, Laboratories, & Analytical Industries.

The incumbent is responsible for all Product Classification/Manufacturing Site Registration and Product Registration and to ensure that all documents required are available and are submitted on time. They are also responsible for the preparation of the pre- and final permits for the imported items as per the SFDA guidelines.

ACCOUNTABILITIES

Regulatory Affairs:

• Ensure that Zahrawi’s products comply with the regulations of the SFDA.
• Keep up to date with the latest changes in regulatory legislation and guidelines.
• Liaise and negotiate with regulatory authority to ensure a smooth registration process.
• Provide advice about regulations to customers/suppliers.
• Analyze product complaints and make recommendations to solve the problem and to avoid them in the future.

Product Classification & Registration:

• Ensure that all required documents and actions for Product Classification/Manufacturing Site Registration and Product Registration are available.
• Prepare all required documents to be submitted for Product Classification under SFDA.
• Prepare all required documents to be submitted for Manufacturing Site registration under SFDA.
• Prepare all the Dossiers to be submitted to SFDA for medical, pharmaceuticals and GSL products.
• Prepare and submit samples to SFDA for product registration completion.
• Collect all necessary documents from Supplier to submit for SFDA of products under Ghad System.
• Register reagents with restricted elements through Ghad System.
• Prepare and apply for the pre-permit document as per the SFDA guidelines and verify the items being imported and the documents required.
• Apply for the MOH Narcotics and Pre-cursor Chemical permits on the SFDA website as per the specified guidelines.
• Register and submit the permits through Ghad system.
• Resubmit any permits that have not been approved and make sure all the information provided is correct and attach any new documents if required.
• Prepare weekly / monthly report regarding the rejections/ delays for SFDA importation permits and reasons related to that.
• Check and review the safety data sheet of the restricted element to prepare the required documents for obtaining MOI approval.
• Prepare the required documents necessary for obtaining SFDA approval to export medical products outside KSA.
• Communicate with the existing and new suppliers regarding SFDA importation rules and policies.
• Upload on the SFDA importation system any new classifications or registration certificates.
• Ensure that all urgent request from the Sales team and suppliers are dealt with in a fast manner and ensure that all documents are in place.
• Report any deviation from SFDA guidelines of imported shipments and take the corrective and preventive action accordingly.
• Review on a regular basis the SFDA importation process of distribution agreements.
• Ensure that the SFDA license is renewed before expiry date to avoid importation disturbance.
• Segregate the imported products as per HS code in coordination with logistic team and confirm if products are SFDA regulated or not.
• Coordinate with the Procurement & Logistics Team to update all the required documents in time to avoid importation rejections.

Audit:

• Prepare any documentation needed for internal and external audits.
• File all documents in the corresponding files to ensure all are available and are correct.
• Evaluate the suggestions after the audit and implement them when possible.

Admin:

• Assist the Warehouse Coordinators with relevant documents when requested.
• Coordinate with the Procurement team and assist them with any question they or the Suppliers may have related to SFDA importation.

Note: Zahrawi employees must step into other work assigned to them as business needs arise and are not limited to the above.

REQUIREMENTS

Education: Bachelor’s degree (Biology/ Pharmacy/ Biomedical or Science related major is an advantage)

Experience: 2-3 years of relevant experience in regulatory affairs

• Job Specific Skills: Effective Communication skills & Good English - Time management skills - Problem Solving Skills - Good computer skills in Ms. Office (Excel– ERP/Oracle system) – Process Management skills – Detail Oriented – Knowledge about Saber System & Ghad System - Knowledge in SFDA regulations.

Additional Details: Candidate should be Saudi National and based in Riyadh, KSA.

Location: KSA - Riyadh

Job Type: FULLTIME

Job Posting Date:

Division/Department: Regulatory Affairs and Pharmacovigilance

Copyright Al-Zahrawi Medical Supplies Est 2019 All rights reserved

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Regulatory Affairs Executive/Specialist - (562)

Zahrawi Group is a leading company in the GCC Healthcare Industry with its presence in UAE, KSA, Qatar, Bahrain, & Oman markets. The company supplies and distributes high-quality products and services to Hospitals, Clinics, Laboratories, & Analytical Industries.

The incumbent is responsible for all Product Classification/Manufacturing Site Registration and Product Registration and to ensure that all documents required are available and are submitted on time. They are also responsible for the preparation of the pre- and final permits for the imported items as per the SFDA guidelines.

ACCOUNTABILITIES

Regulatory Affairs:

• Ensure that Zahrawi's products comply with the regulations of the SFDA.
• Keep up to date with the latest changes in regulatory legislation and guidelines.
• Liaise and negotiate with regulatory authority to ensure a smooth registration process.
• Provide advice about regulations to customers/suppliers.
• Analyze product complaints and make recommendations to solve the problem and to avoid them in the future.

Product Classification & Registration:

• Ensure that all required documents and actions for Product Classification/Manufacturing Site Registration and Product Registration are available.
• Prepare all required documents to be submitted for Product Classification under SFDA.
• Prepare all required documents to be submitted for Manufacturing Site registration under SFDA.
• Prepare all the Dossiers to be submitted to SFDA for medical, pharmaceuticals and GSL products.
• Prepare and submit samples to SFDA for product registration completion.
• Collect all necessary documents from Supplier to submit for SFDA of products under Ghad System.
• Register reagents with restricted elements through Ghad System.
• Prepare and apply for the pre-permit document as per the SFDA guidelines and verify the items being imported and the documents required.
• Apply for the MOH Narcotics and Pre-cursor Chemical permits on the SFDA website as per the specified guidelines.
• Register and submit the permits through Ghad system.
• Resubmit any permits that have not been approved and make sure all the information provided is correct and attach any new documents if required.
• Prepare weekly / monthly report regarding the rejections/ delays for SFDA importation permits and reasons related to that.
• Check and review the safety data sheet of the restricted element to prepare the required documents for obtaining MOI approval.
• Prepare the required documents necessary for obtaining SFDA approval to export medical products outside KSA.
• Communicate with the existing and new suppliers regarding SFDA importation rules and policies.
• Upload on the SFDA importation system any new classifications or registration certificates.
• Ensure that all urgent request from the Sales team and suppliers are dealt with in a fast manner and ensure that all documents are in place.
• Report any deviation from SFDA guidelines of imported shipments and take the corrective and preventive action accordingly.
• Review on a regular basis the SFDA importation process of distribution agreements.
• Ensure that the SFDA license is renewed before expiry date to avoid importation disturbance.
• Segregate the imported products as per HS code in coordination with logistic team and confirm if products are SFDA regulated or not.
• Coordinate with the Procurement & Logistics Team to update all the required documents in time to avoid importation rejections.

Audit:

• Prepare any documentation needed for internal and external audits.
• File all documents in the corresponding files to ensure all are available and are correct.
• Evaluate the suggestions after the audit and implement them when possible.

Admin:

• Assist the Warehouse Coordinators with relevant documents when requested.
• Coordinate with the Procurement team and assist them with any question they or the Suppliers may have related to SFDA importation.

Note: Zahrawi employees must step into other work assigned to them as business needs arise and are not limited to the above.

REQUIREMENTS

Education: Bachelor's degree (Biology/ Pharmacy/ Biomedical or Science related major is an advantage)

Experience: 2-3 years of relevant experience in regulatory affairs

• Job Specific Skills: Effective Communication skills & Good English - Time management skills - Problem Solving Skills - Good computer skills in Ms. Office (Excel- ERP/Oracle system) - Process Management skills - Detail Oriented - Knowledge about Saber System & Ghad System - Knowledge in SFDA regulations.

Additional Details: Candidate should be Saudi National and based in Riyadh, KSA.

Location: KSA - Riyadh

Job Type: FULLTIME

Job Posting Date:

Division/Department: Regulatory Affairs and Pharmacovigilance

Copyright Al-Zahrawi Medical Supplies Est 2019 All rights reserved

Regulatory Affairs Executive/Specialist - (562)

Zahrawi Group is a leading company in the GCC Healthcare Industry with its presence in UAE, KSA, Qatar, Bahrain, & Oman markets. The company supplies and distributes high-quality products and services to Hospitals, Clinics, Laboratories, & Analytical Industries.

The incumbent is responsible for all Product Classification/Manufacturing Site Registration and Product Registration and to ensure that all documents required are available and are submitted on time. They are also responsible for the preparation of the pre- and final permits for the imported items as per the SFDA guidelines.

ACCOUNTABILITIES

Regulatory Affairs:

• Ensure that Zahrawi’s products comply with the regulations of the SFDA.
• Keep up to date with the latest changes in regulatory legislation and guidelines.
• Liaise and negotiate with regulatory authority to ensure a smooth registration process.
• Provide advice about regulations to customers/suppliers.
• Analyze product complaints and make recommendations to solve the problem and to avoid them in the future.

Product Classification & Registration:

• Ensure that all required documents and actions for Product Classification/Manufacturing Site Registration and Product Registration are available.
• Prepare all required documents to be submitted for Product Classification under SFDA.
• Prepare all required documents to be submitted for Manufacturing Site registration under SFDA.
• Prepare all the Dossiers to be submitted to SFDA for medical, pharmaceuticals and GSL products.
• Prepare and submit samples to SFDA for product registration completion.
• Collect all necessary documents from Supplier to submit for SFDA of products under Ghad System.
• Register reagents with restricted elements through Ghad System.
• Prepare and apply for the pre-permit document as per the SFDA guidelines and verify the items being imported and the documents required.
• Apply for the MOH Narcotics and Pre-cursor Chemical permits on the SFDA website as per the specified guidelines.
• Register and submit the permits through Ghad system.
• Resubmit any permits that have not been approved and make sure all the information provided is correct and attach any new documents if required.
• Prepare weekly / monthly report regarding the rejections/ delays for SFDA importation permits and reasons related to that.
• Check and review the safety data sheet of the restricted element to prepare the required documents for obtaining MOI approval.
• Prepare the required documents necessary for obtaining SFDA approval to export medical products outside KSA.
• Communicate with the existing and new suppliers regarding SFDA importation rules and policies.
• Upload on the SFDA importation system any new classifications or registration certificates.
• Ensure that all urgent request from the Sales team and suppliers are dealt with in a fast manner and ensure that all documents are in place.
• Report any deviation from SFDA guidelines of imported shipments and take the corrective and preventive action accordingly.
• Review on a regular basis the SFDA importation process of distribution agreements.
• Ensure that the SFDA license is renewed before expiry date to avoid importation disturbance.
• Segregate the imported products as per HS code in coordination with logistic team and confirm if products are SFDA regulated or not.
• Coordinate with the Procurement & Logistics Team to update all the required documents in time to avoid importation rejections.

Audit:

• Prepare any documentation needed for internal and external audits.
• File all documents in the corresponding files to ensure all are available and are correct.
• Evaluate the suggestions after the audit and implement them when possible.

Admin:

• Assist the Warehouse Coordinators with relevant documents when requested.
• Coordinate with the Procurement team and assist them with any question they or the Suppliers may have related to SFDA importation.

Note: Zahrawi employees must step into other work assigned to them as business needs arise and are not limited to the above.

REQUIREMENTS

Education: Bachelor’s degree (Biology/ Pharmacy/ Biomedical or Science related major is an advantage)

Experience: 2-3 years of relevant experience in regulatory affairs

• Job Specific Skills: Effective Communication skills & Good English - Time management skills - Problem Solving Skills - Good computer skills in Ms. Office (Excel– ERP/Oracle system) – Process Management skills – Detail Oriented – Knowledge about Saber System & Ghad System - Knowledge in SFDA regulations.

Additional Details: Candidate should be Saudi National and based in Riyadh, KSA.

Location: KSA - Riyadh

Job Type: FULLTIME

Job Posting Date:

Division/Department: Regulatory Affairs and Pharmacovigilance

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