23 Regulatory Affairs Specialist jobs in Saudi Arabia

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

Regulatory Affairs & Government Relations (KSA & Other Jurisdictions)

• Act as the primary point of contact with all regulatory bodies in KSA and other relevant jurisdictions.
• Ensure timely, accurate, and legally sound responses to all regulatory inquiries and requirements.
• Monitor emerging regulatory bodies and ensure their integration within the Legal function, in alignment with GRC’s compliance framework.
• Develop and maintain the Regulatory Affairs Policy, ensuring it reflects current legal obligations and operational practices.
• Collaborate with Corporate Planning and relevant business units to support licensing and regulatory filings for existing and new services.
• Coordinate with Giza Arabia, GS companies in KSA, and the KSA GM/Country Head to ensure alignment on country-specific regulatory requirements.
• Support ongoing engagement with CITC and other regulators in collaboration with Legal and internal stakeholders.
• Ensure effective coordination with the Solutions team to align regulatory and operational objectives.

Investigations & Compliance (KSA)

• Lead investigations into violations of regulations, internal policies, and governmental fines issued to the company.
• Conduct structured investigations in KSA, including evidence collection, interviews, documentation, and reporting.
• Prepare formal investigation reports with findings, conclusions, and actionable recommendations.
• Corporate Governance & Board Support (KSA)
• Prepare and review agendas, resolutions, and minutes for Board, OGA, and EOGA meetings for GS companies in KSA.
• Ensure compliance with corporate governance frameworks and regulatory requirements.
• Coordinate logistics and documentation for board and committee meetings.
• Oversee and manage all legal processes related to corporate governance and compliance in KSA.
• Responsible for all related documentations archiving in coordination with the Contracts team, ensuring proper documentation and accessibility.

Legal Advisory & Strategic Support

• Provide legal advice, guidance, and recommendations across GS companies in KSA.
• Respond to executive management inquiries on strategic legal matters, offering insights and risk assessments.
• Advise the GRC team on applicable laws, regulations, and compliance obligations within KSA.

Contract Management & Archiving

• Responsible for contract archiving in coordination with the Contracts team, ensuring proper documentation and accessibility.

Regulatory Affairs & Government Relations (KSA & Other Jurisdictions)

• Act as the primary point of contact with all regulatory bodies in KSA and other relevant jurisdictions.
• Ensure timely, accurate, and legally sound responses to all regulatory inquiries and requirements.
• Monitor emerging regulatory bodies and ensure their integration within the Legal function, in alignment with GRC's compliance framework.
• Develop and maintain the Regulatory Affairs Policy, ensuring it reflects current legal obligations and operational practices.
• Collaborate with Corporate Planning and relevant business units to support licensing and regulatory filings for existing and new services.
• Coordinate with Giza Arabia, GS companies in KSA, and the KSA GM/Country Head to ensure alignment on country-specific regulatory requirements.
• Support ongoing engagement with CITC and other regulators in collaboration with Legal and internal stakeholders.
• Ensure effective coordination with the Solutions team to align regulatory and operational objectives.

Investigations & Compliance (KSA)

• Lead investigations into violations of regulations, internal policies, and governmental fines issued to the company.
• Conduct structured investigations in KSA, including evidence collection, interviews, documentation, and reporting.
• Prepare formal investigation reports with findings, conclusions, and actionable recommendations.
• Corporate Governance & Board Support (KSA)
• Prepare and review agendas, resolutions, and minutes for Board, OGA, and EOGA meetings for GS companies in KSA.
• Ensure compliance with corporate governance frameworks and regulatory requirements.
• Coordinate logistics and documentation for board and committee meetings.
• Oversee and manage all legal processes related to corporate governance and compliance in KSA.
• Responsible for all related documentations archiving in coordination with the Contracts team, ensuring proper documentation and accessibility.

Legal Advisory & Strategic Support

• Provide legal advice, guidance, and recommendations across GS companies in KSA.
• Respond to executive management inquiries on strategic legal matters, offering insights and risk assessments.
• Advise the GRC team on applicable laws, regulations, and compliance obligations within KSA.

Contract Management & Archiving

• Responsible for contract archiving in coordination with the Contracts team, ensuring proper documentation and accessibility.

Specialist, Regulatory Affairs page is loadedSpecialist, 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:

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:

Join to apply for the Sr. Specialist - Regulatory Affairs role at Julphar

Join to apply for the Sr. Specialist - Regulatory Affairs role at Julphar

At Julphar, we are on a journey of culture transformation & our mission is to provide a better quality of life for the entire family by delivering best in class solutions and real value with compassion and professionalism.

Our core values: Respect, Collaboration, innovation, Integrity and Compassion - Combined with a focus on diversity, inclusion, and equal opportunities - are key drivers in our aim to make a positive impact on the lives of the patients we serve, enable Talents , create a healthy work environment, and accomplish our goals through world-class research and with the compassion and commitment of our employees.

Designation: Regulatory Affair Senior Officer

Department: Scientific Office / Riyadh K.S.A

Summary Of Responsibilities

• To facilitate all regulatory activities between Julphar headquarter and the local authority.
• To review and coordinate a database for regulatory activities and documentation.
• Provide input to strategic decisions affecting the functional areas of responsibility.
  
  

• Liaise with RA-HQ for annual regulatory activity plans (new registrations, renewals, post-approval activities).
• Acknowledge receipt of regulatory files from RA-HQ and provide expected submission dates to Health Authority (HA).
• Review regulatory files before HA submission to ensure compliance with guidelines, scientific accuracy, clarity, and to expedite submission.
• Maintain effective relationships with health authorities, liaise, and negotiate when necessary.
• Provide acknowledgment receipt to RA-HQ upon submission of each application.
• Follow up regularly with regulatory authorities on submitted applications.
• Receive authority queries, filter fulfilled requirements, and forward to RA-HQ within 2 working days.
• Collaborate with RA-HQ to ensure timely compliance with authority timelines and coordinate with HA for timeline extensions if needed.
• Review and confirm HA registration certificates/decisions for discrepancies and share approval decisions with RA-HQ within 3 working days.
• Review the master regulatory tracker regularly and communicate updates to RA-HQ within 2 days.
• Interpret authority rules and changes, and update RA-HQ with circulars, new decisions, and guideline updates within 3 working days.
• Report any change in product pricing to RA-HQ immediately.
• Provide a monthly report for all regulatory transactions, including submissions, approvals, and query handling.
• Be proactive in the dynamic regulatory environment of the region/countries, especially regarding guidelines and pricing, and provide necessary feedback.
  
  

• Bachelor of Pharmacy.
  
  

• Computer skills (Ms Office, Google Drive, spreadsheet, and database).
• Planning (Assessment, analysis, problem solving, collaboration and communication skills).
• Management skills (prioritization, task separation and multiple task handling).
• Good communication and presentation skills.
• Maintaining a comprehensive knowledge of local authority regulation and sufficient knowledge of global regulatory legislation and guidelines
  
  

• Seniority level Mid-Senior level

• Employment type Full-time

• Job function Legal
• Industries Pharmaceutical Manufacturing

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Riyadh, Riyadh, Saudi Arabia 22 hours ago

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Specialist, Quality & Regulatory Affairs

At Cardinal Health, we aim to be a trusted partner, offering a broad range of innovative solutions that help our customers provide cost-efficient, more effective healthcare. Join our team of 50,000 humble partners striving each day to make healthcare more efficient, providers more effective, and patients as healthy as possible.

We are currently looking to recruit a Specialist Quality & Regulatory Affairs based in our Riyadh office in Saudi Arabia, reporting to the Quality and Regulatory Affairs Manager, you will be responsible for, but not limited to, the following:

• Ensuring accurate and timely registration of products with competent authorities for KSA and other EMEA markets.

• Provide Quality & Regulatory Affairs support for EMEA markets, in compliance with applicable regulations and standards to ensure timely commercialization of products.

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

• Support regional distribution control (in compliance with applicable regulations and standards) to ensure timely commercialization of products.

• Review and validate regulatory data executing outbound flow.

• Ensure deployment and improvement of regulatory document related to new project development.

• Support as required the EMEA QRA team to ensure quality and regulatory compliance in accordance with national and European regulations.

• Act as the QRA representative in regional project meeting.

Essential Functions and Responsibilities

With moderate supervision, you will be responsible for the following Regulatory and Quality activities:

• Developing and implementing regulatory strategies and processes to ensure timely commercialization of products in compliance with applicable regulations and standards.

• Preparing documentation to support product registration and modifications according to project phase implementation.

• Overall registration strategies, coordination, implementation, execution, control and completion of product registrations in EMEA countries.

• Providing Regulatory intelligence.

• Supporting communication with our local agent and distributors in EMEA countries.

• Acting as QRA representative in the project implementation and work activity with various stakeholders.

• Notification to the regional quality and regulatory team for sharing status’ & updates of ongoing projects.

• Monitoring of local Regulatory environment, new regulations and supporting feedback and gap assessments to international Regulatory departments and business partners that impact projects.

• Ensuring follow-up/improvement of the distribution control procedure.

• Maintaining and archiving of all regulatory documentation in the region.

• Where needed, supporting the reporting of Serious Adverse Events to Competent Authority(ies) in EMEA.

• Ensuring compliance with quality procedures, laws and regulations of the applicable markets.

• Communicating business related issues or opportunities to next management level.

• Ensuring personal and company compliance with all local and company regulations, policies, and procedures.

• Training and deployment of local tools related to distribution control.

• Ensuring QRA administrative tasks related to assigned projects are completed.

• Perform other duties assigned as needed.

Qualifications and Experience

• BA/BS in Scientific discipline or equivalent work experience (3 years min).

• BS degree in Pharmacy, Medicine, Physical or Biological science or similar obtained by experience.

• Minimum of 3 years’ experience in Regulatory Affairs in Saudi Arabia and MEA region.

• Fluency in written and verbal English and Arabic is mandatory.

• Consistent background and knowledge of SFDA regulations for Medical Devices, strong connections with SFDA will be preferred.

• Must be proficient with MS Office applications.

• Excellent communication skills (verbal and written).

• Project management skills preferred.

• Problem solving skills.

• Presentation skills preferred.

• High degree of initiative.

• Open minded, listens to others.

• Able to manage complexity within a matrix organization.

• At ease in international environment.

• Hands on/can do attitude.

• Excellent attention to details.

Benefits

• Comprehensive local medical insurance for the employee and his/her family

• Various allowances

• Long term disability support, etc.

The Company

Headquartered in Dublin, Ohio, Cardinal Health (NYSE: CAH) is a health care services company that improves the cost-effectiveness of healthcare. As the business behind healthcare, Cardinal Health helps pharmacies, hospitals and ambulatory care sites focus on patient care while reducing costs, improving efficiency and quality, and increasing profitability. Cardinal Health is an essential link in the healthcare supply chain, providing pharmaceuticals and medical products to more than 100,000 locations each day and is also the industry-leading direct-to-home medical supplies distributor. The company is a leading manufacturer of medical and surgical products, including gloves, surgical apparel and fluid management products. In addition, the company supports the growing diagnostic industry by supplying medical products to clinical laboratories and operating the nation's largest network of radio pharmacies that dispense products to aid in the early diagnosis and treatment of disease. Ranked #14 on the Fortune 500 , Cardinal Health employs more than 50,000 people worldwide .

Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply.

Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.

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