29 Policy Lead jobs in Saudi Arabia

The Regulatory Affairs Specialist plays a crucial role in ensuring that medical and healthcare equipment complies with all regulations and standards set by governmental and international bodies. This position involves a deep understanding of the regulatory landscape and the ability to navigate complex compliance requirements. The specialist will be responsible for preparing and submitting regulatory documents, managing product registrations, and ensuring that all products meet safety and efficacy standards before they reach the market. This role is essential for maintaining the company's reputation and ensuring the safety of healthcare products.

Responsibilities:

1. Prepare and submit regulatory documents to ensure compliance with local and international regulations.
2. Manage product registrations and maintain up-to-date records of regulatory submissions.
3. Conduct thorough reviews of product labeling and promotional materials for compliance.
4. Collaborate with cross-functional teams to ensure that product development aligns with regulatory requirements.
5. Monitor changes in regulations and assess their impact on the company's products.
6. Provide guidance and training to internal teams on regulatory requirements and best practices.
7. Prepare for and participate in regulatory inspections and audits.
8. Develop and maintain relationships with regulatory agencies.
9. Assist in the preparation of responses to regulatory inquiries and issues.
10. Support the development of regulatory strategies for new products and market expansions.

Preferred Candidate:

1. Strong analytical and problem-solving skills.
2. Excellent communication and interpersonal abilities.
3. Detail-oriented with a high level of accuracy.
4. Ability to work independently and manage multiple projects simultaneously.
5. Proficient in regulatory documentation and submission processes.
6. Experience in the medical device or healthcare industry.
7. Knowledge of quality management systems and standards.
8. Ability to adapt to changing regulations and industry trends.
9. Strong organizational skills and time management.
10. Commitment to continuous professional development in regulatory affairs.

Skills

• In-depth knowledge of regulatory requirements for medical devices.
• Strong understanding of quality management systems (QMS) ISO 13485.
• Proficient in regulatory submission software and tools.
• Excellent written and verbal communication skills.
• Ability to interpret complex regulations and guidelines.
• Strong project management skills.
• Familiarity with clinical trial processes and documentation.
• Ability to work collaboratively in a team environment.

The Regulatory Affairs Specialist plays a crucial role in ensuring that medical and healthcare equipment complies with all regulations and standards set by governmental and international bodies. This position involves a deep understanding of the regulatory landscape and the ability to navigate complex compliance requirements. The specialist will be responsible for preparing and submitting regulatory documents, managing product registrations, and ensuring that all products meet safety and efficacy standards before they reach the market. This role is essential for maintaining the company's reputation and ensuring the safety of healthcare products.

Responsibilities:

1. Prepare and submit regulatory documents to ensure compliance with local and international regulations.
2. Manage product registrations and maintain up-to-date records of regulatory submissions.
3. Conduct thorough reviews of product labeling and promotional materials for compliance.
4. Collaborate with cross-functional teams to ensure that product development aligns with regulatory requirements.
5. Monitor changes in regulations and assess their impact on the company's products.
6. Provide guidance and training to internal teams on regulatory requirements and best practices.
7. Prepare for and participate in regulatory inspections and audits.
8. Develop and maintain relationships with regulatory agencies.
9. Assist in the preparation of responses to regulatory inquiries and issues.
10. Support the development of regulatory strategies for new products and market expansions.

Preferred Candidate:

1. Strong analytical and problem-solving skills.
2. Excellent communication and interpersonal abilities.
3. Detail-oriented with a high level of accuracy.
4. Ability to work independently and manage multiple projects simultaneously.
5. Proficient in regulatory documentation and submission processes.
6. Experience in the medical device or healthcare industry.
7. Knowledge of quality management systems and standards.
8. Ability to adapt to changing regulations and industry trends.
9. Strong organizational skills and time management.
10. Commitment to continuous professional development in regulatory affairs.

Skills

• In-depth knowledge of regulatory requirements for medical devices.
• Strong understanding of quality management systems (QMS) ISO 13485.
• Proficient in regulatory submission software and tools.
• Excellent written and verbal communication skills.
• Ability to interpret complex regulations and guidelines.
• Strong project management skills.
• Familiarity with clinical trial processes and documentation.
• Ability to work collaboratively in a team environment.

Specialist, Regulatory Affairs page is loaded Specialist, Regulatory Affairs Apply locations SA Riyadh time type Full time posted on Posted 8 Days Ago job requisition id JR1999 ARA-P1-10

Responsible for dossier compilation and submission • Responsible for ensuring compliant life cycle management in compliance with market regulations • Manage local Labeling and AWs creation and submission • Maintain the regulatory processes within the department, including assist with the development and implementation of regulatory procedures and SOP, • Manage Communication with regulatory agencies or related interface

Additional Job Description:

Primary Location:

Job Posting Date:

Job Type:

Mundipharma is a global healthcare company with a presence across Africa, Asia Pacific, Canada, Europe, Latin America, and the Middle East.

Mundipharma is dedicated to bringing innovative treatments to patients in the areas of Pain Management, Infectious Disease and Consumer Healthcare as well as other severe and debilitating disease areas. Our guiding principles, centered around Integrity and Patient-Centricity, are at the heart of everything we do.

For more information about Mundipharma's guiding principles and commitment to diversity and inclusion visit:

The Regulatory Affairs Specialist plays a crucial role in ensuring that medical and healthcare equipment complies with all regulations and standards set by governmental and international bodies. This position involves a deep understanding of the regulatory landscape and the ability to navigate complex compliance requirements. The specialist will be responsible for preparing and submitting regulatory documents, managing product registrations, and ensuring that all products meet safety and efficacy standards before they reach the market. This role is essential for maintaining the company's reputation and ensuring the safety of healthcare products.

Responsibilities:

1. Prepare and submit regulatory documents to ensure compliance with local and international regulations.
2. Manage product registrations and maintain up-to-date records of regulatory submissions.
3. Conduct thorough reviews of product labeling and promotional materials for compliance.
4. Collaborate with cross-functional teams to ensure that product development aligns with regulatory requirements.
5. Monitor changes in regulations and assess their impact on the company's products.
6. Provide guidance and training to internal teams on regulatory requirements and best practices.
7. Prepare for and participate in regulatory inspections and audits.
8. Develop and maintain relationships with regulatory agencies.
9. Assist in the preparation of responses to regulatory inquiries and issues.
10. Support the development of regulatory strategies for new products and market expansions.

Preferred Candidate:

1. Strong analytical and problem-solving skills.
2. Excellent communication and interpersonal abilities.
3. Detail-oriented with a high level of accuracy.
4. Ability to work independently and manage multiple projects simultaneously.
5. Proficient in regulatory documentation and submission processes.
6. Experience in the medical device or healthcare industry.
7. Knowledge of quality management systems and standards.
8. Ability to adapt to changing regulations and industry trends.
9. Strong organizational skills and time management.
10. Commitment to continuous professional development in regulatory affairs.

Skills

• In-depth knowledge of regulatory requirements for medical devices.
• Strong understanding of quality management systems (QMS) ISO 13485.
• Proficient in regulatory submission software and tools.
• Excellent written and verbal communication skills.
• Ability to interpret complex regulations and guidelines.
• Strong project management skills.
• Familiarity with clinical trial processes and documentation.
• Ability to work collaboratively in a team environment.

Overview

Regulatory Affairs Specialist - KSA

Company: Servier

Location: Riyadh, Saudi Arabia

Type: Full-time Employment / Unlimited

Date posted: Sep 10, 2025

• 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

• 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.

Regulatory Affairs Specialist - KSA

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• 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.

• 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.

• 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.

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

• 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.

• 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.

• 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.

• 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.

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.

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.

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

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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Join to apply for the Regulatory Affairs Specialist KSA role at Galderma .

Galderma is the emerging pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare, and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body's largest organ - the skin - meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand the skin, we are shaping our lives, and we are advancing dermatology for every skin story.

We look for people who focus on results, embrace learning, and bring positive energy. They must combine initiative with teamwork and collaboration. Above all, they must be passionate about making a meaningful impact for consumers, patients, and healthcare professionals. We aim to empower employees and promote personal growth while meeting business needs now and in the future. We embrace diversity and respect the dignity, privacy, and personal rights of every employee.

At Galderma, we are committed to becoming the leading dermatology company in the world. Join us to gain new experiences and create an impact.

Location: KSA, Riyadh

The RA Specialist will manage local regulatory activities to ensure compliance for KSA (70%) and UAE (30%). They will support the RA manager in operational submissions, ensure compliance with all RA and SO responsibilities, and be prepared for audits by HA. The role includes ensuring business continuity, serving as a backup for the RA manager in KSA, and supporting QA and PV functions. The specialist will provide strategic and operational support for product renewals, maintenance, and variations, maintaining momentum to comply with SFDA guidelines.

• Manage registration processes for new products and amendments
• Develop and execute registration strategies in collaboration with Global and local RA teams
• Ensure compliance with evolving regulatory frameworks in KSA and UAE
• Maintain existing product licenses
• Support high-quality and timely submissions; enhance regulatory intelligence; maintain databases for record retention and submission tracking
• Communicate application progress to stakeholders
• Manage regulatory files and documentation; support process improvements and internalize outsourced activities

• Pharmacist or Pharmaceutical Sciences degree
• Saudi MOH license and Saudi nationality
• 4-5 years' experience in regulatory affairs related to medicinal products and medical devices in Saudi Arabia & UAE
• Strong understanding of the pharmaceutical industry and SFDA connections preferred
• Knowledge of Pharmacovigilance and quality systems preferred
• Computer literacy and familiarity with electronic documentation systems
• Fluent in English and Arabic, both written and verbal

• Inclusive work environment embracing diversity
• Competitive compensation, bonus, and benefits
• Growth opportunities with ownership from day one

• Apply with an English CV
• If shortlisted, participate in virtual interviews with recruiter, hiring manager, and team panels

• Seniority level: Mid-Senior
• Employment type: Full-time
• Job function: Legal
• Industry: Pharmaceutical Manufacturing