19 Financial Regulations jobs in Riyadh

Accountabilities Regulatory Affairs

• Ensure that Zahrawis 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.

Importation Permits

• 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.

Exportation Permits

• Prepare the required documents necessary for obtaining SFDA approval to export medical products outside KSA.

Importation Rules & Regulations

• 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.

Requirements

• Education: Bachelors degree.
• Experience: 2+ years of relevant experience in Regulatory Affairs of Medical Devices
• Job Specific Skills: Excellent Communication skills (English & Arabic), Good MS. Office skills, Knowledge about Saber System & Ghad System - Knowledge in SFDA regulations.
• Office Duty: Sunday till Thursday (from 8:00 am 5:00 pm)

#J-18808-Ljbffr

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

#J-18808-Ljbffr

Accountabilities Regulatory Affairs

• Ensure that Zahrawis 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.

Importation Permits

• 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.

Exportation Permits

• Prepare the required documents necessary for obtaining SFDA approval to export medical products outside KSA.

Importation Rules & Regulations

• 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.

Requirements

• Education: Bachelors degree.
• Experience: 2+ years of relevant experience in Regulatory Affairs of Medical Devices
• Job Specific Skills: Excellent Communication skills (English & Arabic), Good MS. Office skills, Knowledge about Saber System & Ghad System - Knowledge in SFDA regulations.
• Office Duty: Sunday till Thursday (from 8:00 am 5:00 pm)

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

Copyright Al-Zahrawi Medical Supplies Est 2019 All rights reserved

#J-18808-Ljbffr

**Regulatory Affairs Specialist, KSA**:

- Work mode: Hybrid- Onsite Location(s): Riyadh, SA**Additional Locations**: N/A

**Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance**

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing - whatever your ambitions.

As an Regulatory Affairs Specialist, you will be responsible of supporting the regulatory submission and provide input on regulatory-related issues associated with compliance and achieving the business plan for assigned countries, in Middle East.
- Key Responsibilities:_
- Prioritize and plan on product registration for his/her respective product lines.
- Maintain an active knowledge of the status of pending approvals /submissions, and shepherd registrations through the approval process.
- Provide the management team with regular updates on product registration.
- Ensure product registrations files are reviewed and renewed as required.
- Supports tender operations by timely supply of accurate regulatory documents.
- Establish and maintain a good working relationship with regional RA peers to gain positive & timely support for document preparation.
- Ensures to meet additional Regulatory project requirements support if assigned and when needed.
- Required Skills and Qualifications:_
- BS in Scientific discipline/engineering preferred
- Has the at least 2 to 3 years’ experience in Regulatory environment
- Knowledge and experience of local regulations and standards.
- Must highly have organization skills / and can manage multitask in very competitive environment.

**Requisition ID**:

**Job Segment**:Regulatory Affairs, Compliance, Law, Engineer, Supply, Legal, Engineering, Operations

About Dexcom

Founded in 1999, Dexcom, Inc. (NASDAQ: DXCM), develops and markets Continuous Glucose Monitoring (CGM) systems for ambulatory use by people with diabetes and by healthcare providers for the treatment of people with diabetes. The company is the leader in transforming diabetes care and management by providing CGM technology to help patients and healthcare professionals better manage diabetes. Since the company’s inception, Dexcom has focused on better outcomes for patients, caregivers, and clinicians by delivering solutions that are best in class - while empowering the community to take control of diabetes. Dexcom reported full-year 2022 revenues of $2.9B, a growth of 18% over 2021. Headquartered in San Diego, California, with additional offices in the Americas, Europe, and Asia Pacific, the company employs over 8,000 people worldwide.

**Summary**:
**Functional Description**:

- Performs the coordination and preparation of document packages for regulatory submissions for new and mature products to ensure alignment and compliance with local and regional registration requirements as well as with company policies from all areas of company as well as internal audits and inspections.
- Compiles all materials required in submissions, license renewal and annual registrations.
- Recommends changes for labelling, manufacturing, marketing and clinical protocol for regulatory compliance.
- Monitors and improves tracking/control systems.
- Keeps abreast of regulatory procedures and changes.
- May direct interaction with regulatory agencies on defined matters.

**Essential Duties and Responsibilities**:

- Leverage software and/or data analytics expertise to develop streamlined regulatory pathways for complex and innovative data-driven products.
- Represent Regulatory Affairs on various cross-functional teams:

- Design Control
- Contribute to the development of the project plan and other deliverables.
- Represent Regulatory Affairs in the development of Product Plans, Specifications, Risk Management and other required documents in MENA region
- Participate in Design Reviews when appropriate
- Document Control
- Regulatory Affairs is a standing member of the Change Control Board (CCB)
- Create and revise procedures as needed.
- Review and approve change orders and evaluate for submission requirements.
- Internal Audits
- Participate as an auditor, independently if appropriately trained
- Other duties as assigned.

**Required Qualifications**:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Requires a minimum of 5 years of related experience with a Bachelor’s degree; or 3 years and a Master’s degree; or a PhD without experience; or equivalent work experience.
- Must have strong writing, editing and analytical skills and have experience in developing complex submissions with mínimal supervision.
- Knowledge of MENA region US and international regulatory requirements including clinical regulations, design control, medical device submissions requirements, labelling and promotion regulations, quality control, auditing principles, and adverse event reports.
- Must work well independently or within a cross-functional team environment.

**Preferred Qualifications**:

- Experience in a regulated medical device company in regulatory, clinical affairs, engineering or quality assurance
- Extensive knowledge of US FDA and EU Medical Device Regulation requirements for the submission of pre
- and post-market clinical trial data and reports in the MENA region
- CER development under MEDDEV rev. 4 and EU MDR guidance
- Familiarity with clinical study designs and biostatistics
- Previous work in or with Clinical or Medical Affairs with a background in science or an aptitude for scientific disciplines, such as clinical data analysis or biomedical engineering

**Functional/Business Knowledge**:

- A seasoned, experienced professional with a full understanding of area of specialization; resolves a wide range of issues in creative ways.
- Demonstrates further technical development and a track record of project success.
- Demonstrates an ability to coordinate multiple projects simultaneously.
- Considered a specialist in the field within the function.

**Scope**:

- Assists in determining objectives of assignment. Plan schedules and arranges own activities in accomplishing objectives.
- Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors.
- Networks with senior internal and external colleagues in own area of expertise.

**Judgement**:

- Demonstrates good judgement in selecting methods and techniques for obtaining solutions.
- Normally receives little instruction on day ‐ to ‐ day work, general instr

Regulatory Affairs TSO Manager KSA page is loadedRegulatory Affairs TSO Manager KSA Apply locations SA Riyadh time type Full time posted on Posted 4 Days Ago job requisition id JR2036 ARA-P3-12

Regulatory Affairs TSO Manager

Location: Riyadh, KSA

Department: Regulatory Affairs

Job type: Permanent

Join us and make a difference when it matters most!

At Mundipharma, we are proud of the work we do to bring innovative treatments to patients. We challenge ourselves constantly to deliver more for patients, healthcare professionals, our partners, and our employees.

The Team

The role will join the Regulatory Affairs team in Riyadh, accountable for the regulatory affairs in Saudi, driving optimal regulatory outcomes and ensuring governance on regulatory activities. You will support PV Operations leadership as needed and act as TSO manager in KSA on behalf of the company.

Role and Responsibilities

• Ensure full compliance to all local and international regulations, codes and standards and company SOP.
• Prioritize assignments between RA and TSO aspects of role and co-ordinate multiple projects and activities accordance with company objectives.
• Be responsible for regulatory submissions and responses to deficiency letters, and timely tracking status of the progress, including new product registration, line extensions, variations, renewal and manufacturing site certificate application and maintenance.
• Ensure filing strategy is aligned with global strategy.
• Gather and share regulatory or safety intelligence such as current developments in the medical and scientific communities which may impact products and business with stakeholders.
• Ensure maintenance of appropriate systems for Regulatory activities and documentation.
• Ensure regulatory budget is prepared and maintained and aligned with global budget requirements.
• Establish and implement plans to maintain a trusted relationship with local authorities through regular meeting and discussions where appropriate.
• Ensure validity of Scientific Office licenses based on Local HA regulations.
• Respond to authorities’ inquiries related to Scientific Office.

What you’ll bring

• Bachelor’s degree or equivalent or higher, in Pharmacy
• Saudi National with a Pharmacist license from the Saudi Council of Health Specialities
• At least 5 years’ experience in regulatory affairs dealing with a wide variety of registration projects and issues.
• Experience in dealing with Pharmacovigilance matters.
• Thorough understanding and demonstrated ability to apply regulatory guidelines/regulations to successful dossier preparation, submission and maintenance.
• Ability to develop strategies and solutions within the regulatory and safety context within the scope of global requirements and available resources.
• Strong initiation and organization skills
• Outstanding written and oral communication and negotiation skills.
• Knowledge, experience and track record of delivering successful outcomes for regulatory, safety and TSO activities
• Good technical skills in the local HA online submission system or equivalent systems

What we offer in return

• Opportunities for learning & development through our varied programme
• Collaborative, inclusive work environment

Diversity and inclusion

Building an inclusive environment where people can thrive, grow and achieve their full potential is a priority. We believe this isn’t just the right thing, but also the smart thing to do. We are on a journey and will seek to move forward together through education and awareness to build a culture that welcomes and celebrates diversity and uniqueness. We will create a workplace environment where everyone can, every day, bring their authentic selves and is treated with dignity and respect.

About Mundipharma

Mundipharma is a global healthcare company focussing on customers 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 as well as other severe and debilitating disease areas. Their guiding principles, centered around Integrity and Patient-Centricity, are at the heart of everything they do. For more information visit

Join our talent pool

If you’re not sure this role is right for you but you’re keen to hear about future opportunities at Mundipharma, join our talent community and be the first to hear about new roles.

Additional Job Description:

Primary Location:

SA Riyadh

Job Posting Date:

Job Type:

Permanent

About Us

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:

#J-18808-Ljbffr

Regulatory Affairs TSO Manager KSA page is loaded Regulatory Affairs TSO Manager KSA Apply locations SA Riyadh time type Full time posted on Posted 4 Days Ago job requisition id JR2036 ARA-P3-12

Regulatory Affairs TSO Manager

Location: Riyadh, KSA

Department: Regulatory Affairs

Job type: Permanent

Join us and make a difference when it matters most!

At Mundipharma, we are proud of the work we do to bring innovative treatments to patients. We challenge ourselves constantly to deliver more for patients, healthcare professionals, our partners, and our employees.

The Team

The role will join the Regulatory Affairs team in Riyadh, accountable for the regulatory affairs in Saudi, driving optimal regulatory outcomes and ensuring governance on regulatory activities. You will support PV Operations leadership as needed and act as TSO manager in KSA on behalf of the company.

Role and Responsibilities

• Ensure full compliance to all local and international regulations, codes and standards and company SOP.
• Prioritize assignments between RA and TSO aspects of role and co-ordinate multiple projects and activities accordance with company objectives.
• Be responsible for regulatory submissions and responses to deficiency letters, and timely tracking status of the progress, including new product registration, line extensions, variations, renewal and manufacturing site certificate application and maintenance.
• Ensure filing strategy is aligned with global strategy.
• Gather and share regulatory or safety intelligence such as current developments in the medical and scientific communities which may impact products and business with stakeholders.
• Ensure maintenance of appropriate systems for Regulatory activities and documentation.
• Ensure regulatory budget is prepared and maintained and aligned with global budget requirements.
• Establish and implement plans to maintain a trusted relationship with local authorities through regular meeting and discussions where appropriate.
• Ensure validity of Scientific Office licenses based on Local HA regulations.
• Respond to authorities' inquiries related to Scientific Office.

What you'll bring

• Bachelor's degree or equivalent or higher, in Pharmacy
• Saudi National with a Pharmacist license from the Saudi Council of Health Specialities
• At least 5 years' experience in regulatory affairs dealing with a wide variety of registration projects and issues.
• Experience in dealing with Pharmacovigilance matters.
• Thorough understanding and demonstrated ability to apply regulatory guidelines/regulations to successful dossier preparation, submission and maintenance.
• Ability to develop strategies and solutions within the regulatory and safety context within the scope of global requirements and available resources.
• Strong initiation and organization skills
• Outstanding written and oral communication and negotiation skills.
• Knowledge, experience and track record of delivering successful outcomes for regulatory, safety and TSO activities
• Good technical skills in the local HA online submission system or equivalent systems

What we offer in return

• Opportunities for learning & development through our varied programme
• Collaborative, inclusive work environment

Diversity and inclusion

Building an inclusive environment where people can thrive, grow and achieve their full potential is a priority. We believe this isn't just the right thing, but also the smart thing to do. We are on a journey and will seek to move forward together through education and awareness to build a culture that welcomes and celebrates diversity and uniqueness. We will create a workplace environment where everyone can, every day, bring their authentic selves and is treated with dignity and respect.

About Mundipharma

Mundipharma is a global healthcare company focussing on customers 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 as well as other severe and debilitating disease areas. Their guiding principles, centered around Integrity and Patient-Centricity, are at the heart of everything they do. For more information visit .

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Additional Job Description:

Primary Location:

SA Riyadh

Job Posting Date:

Job Type:

Permanent

About Us

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: