48 Regulatory Affairs Departments jobs in Saudi Arabia

We are seeking a detail-oriented and experienced Regulatory Affairs Officer to join our team in Jeddah. The ideal candidate will be responsible for managing all regulatory activities related to medical devices and healthcare products, ensuring full compliance with SFDA (Saudi Food & Drug Authority) and other relevant authorities.

• Prepare, submit, and follow up on MDMA (Medical Device Marketing Authorization) applications with SFDA.
• Coordinate and maintain product registrations, renewals, and variations in compliance with local regulations.
• Ensure all products meet SFDA, GHTF, IMDRF and international regulatory requirements.
• Liaise with suppliers, manufacturers, and distributors to obtain and compile regulatory documentation.
• Manage the importation process, including preparation and submission of clearance documents for shipment release.
• Follow up with customs brokers, clearing agents, and SFDA inspectors to ensure timely clearance of shipments.
• Ensure correct labeling, documentation, and product classification according to SFDA guidelines.
• Monitor regulatory updates, circulars, and announcements to ensure company compliance at all times.
• Assist in audits, inspections, and internal compliance reviews.
• Maintain a regulatory database and proper filing system for all approvals, licenses, and permits.

• Bachelor's degree in Pharmacy, Biomedical Engineering, Life Sciences, or a related field.
• Proven experience (2-4 years) in Regulatory Affairs within the medical device (NEW IVDR REGULATIONS) in KSA.
• Strong knowledge of SFDA e-portal (GHAD, MDMA, SABER) and customs clearance procedures.
• Excellent communication skills in both English and Arabic.
• Strong organizational skills and attention to detail.
• Ability to work independently and handle multiple regulatory projects simultaneously.

• Competitive salary and benefits package.
• Opportunity to grow within a dynamic and expanding organization.
• A professional and collaborative work environment.

1. Functioning independently with a high degree.
2. Assigning markets, ensuring timely file preparation, requirements preparation & submissions for Pharma Products, Cosmetic, Healthcare/Herbal, Medical Device & Food.
3. Tracking the SFDA & GHC registered files. (New Submissions – Variations – Renewals).
4. Ensuring high quality labeling, translation, updating & artwork management for assigned markets.
5. ensuring providing support documents for the export market such as export permits, CPP's, FSC's & GMP's for assigned markets.
6. Communicating with the SFDA, GHC and appropriate follow up for different matters.
7. Maintain cooperative and productive relationships with the other departments in the company.
8. Maintenance/records of Regulatory Documents.
9. Working with the SFDA & GHC software systems such as (eSDR, GHAD, TAAWON, T&D, FASEH, DENR, etc.).
10. Archiving system and backups.
11. Communicating with factory (QA, R&D, etc.).
12. Following up with the SFDA & GHC for new guidelines.
13. Working knowledge of handling eCTD software.
14. Finalizing & follow up with SFDA & GHC to upload our products onto the system.
15. Submit & finalizing the approval for our products with SFDA & GHC.
16. Experience in preparing and evaluating SFDA & GHC dossier (from M1-M5).
17. Preparing letters & follow up with SFDA & GHC if there is any technical issues or if we need any meeting with them.

Job Title: Regulatory Affairs Lead

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines for some of the world’s most serious diseases.

Role Summary

The Regulatory Affairs Lead is responsible for driving regulatory strategies and managing submissions across the product lifecycle to ensure compliance with local and global requirements. The role provides expert advice on processes and documentation, proactively manages regulatory risks, and partners with health authorities and internal stakeholders to enable timely patient access to innovative medicines.

Responsibilities:

• Lead submission management and cross-functional teams for complex global regulatory applications, ensuring compliance with AstraZeneca’s submission-ready standards.
• Provide regulatory expertise and strategic input to product and project teams, anticipating Health Authority requirements and guiding submissions-related activities.
• Identify potential regulatory risks to global and regional operational plans, proposing mitigation strategies.
• Implement and oversee strategies that improve the quality, efficiency, and timeliness of submissions.
• Manage processes related to product licenses, registrations, and post-marketing requirements, including labeling, safety reporting, inspections, and audits.
• Act as the primary regulatory contact with key authorities and ensure timely updates to global systems on regulatory guidelines, decrees, and communications.

Requirements:

• Saudi National
• Higher education in pharmaceuticals, medicine, or biotechnology.
• Minimum 9 years’ experience in regulatory affairs, including at least 5 years in a multinational environment with proven contributions.
• Strong knowledge of local and international regulatory standards, requirements, and industry practices.
• Demonstrated ability to manage pivotal projects and resource requirements.
• Excellent collaboration and teamworking skills across global functions.
• Proven people management capabilities.
• Strong business acumen, including financial and strategic awareness.

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.

JOB TITLE

Regulatory Affairs Lead

ABOUT ASTRAZENECA

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines for some of the world’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies.

ROLE SUMMARY

The Regulatory Affairs Lead is responsible for driving regulatory strategies and managing submissions across the product lifecycle to ensure compliance with local and global requirements. The role provides expert advice on processes and documentation, proactively manages regulatory risks, and partners with health authorities and internal stakeholders to enable timely patient access to innovative medicines.

What you’ll do

Regulatory Strategy & Submissions

• Lead submission management and cross-functional teams for complex global regulatory applications, ensuring compliance with AstraZeneca’s submission-ready standards.
• Provide regulatory expertise and strategic input to product and project teams, anticipating Health Authority requirements and guiding submissions-related activities.
• Identify potential regulatory risks to global and regional operational plans, proposing mitigation strategies.
• Implement and oversee strategies that improve the quality, efficiency, and timeliness of submissions.
• Manage processes related to product licenses, registrations, and post-marketing requirements, including labeling, safety reporting, inspections, and audits.
• Act as the primary regulatory contact with key authorities (e.g., SFDA, GHC) and ensure timely updates to global systems on regulatory guidelines, decrees, and communications.

Business Partnering & Country RA Agenda

• Serve as the regulatory contact for the Country Head and Business Unit Directors (BUDs).
• Conduct regular meetings with local agents’ regulatory teams to align on outstanding activities and ensure smooth execution.
• Foster alignment across therapy area RA managers, local agents, and global stakeholders on regulatory priorities.
• Represent AstraZeneca’s regulatory interests in official engagements with authorities and industry forums.

Leadership & People Development

• Manage and develop a small team of regulatory professionals (1–2 direct reports), setting clear objectives, coaching, and providing growth opportunities.
• Promote a culture of collaboration, creativity, and courageous leadership across teams.
• Lead or participate in critical projects, ensuring regulatory business needs are integrated into AZ’s systems, processes, and standards.

External Engagement & Business Awareness

• Build and maintain strong relationships with Regulatory Health Authorities, industry representatives, and key external partners.
• Monitor regulatory, policy, and industry dynamics, proactively advising internal stakeholders on potential impacts.
• Support business development activities, including proposals, reports, costing, and budgets, ensuring alignment with corporate strategy.

Governance & Compliance

• Ensure all regulatory activities adhere to AstraZeneca’s Code of Ethics, corporate policies, and local legislation.
• Timely reporting of adverse events, compliance risks, conflicts of interest, and health/environment-related incidents.
• Provide regulatory input for audits, inspections, recalls, and related communications to minimize compliance risks.

Essential for the role

• Saudi National
• Higher education in pharmaceuticals, medicine, or biotechnology.
• Minimum 9 years’ experience in regulatory affairs (drug development, product approval/launch, line extension, license maintenance, or Health Authority experience), including at least 5 years in a multinational environment with proven contributions.
• Strong knowledge of local and international regulatory standards, requirements, and industry practices.
• Demonstrated ability to manage pivotal projects and resource requirements.
• Excellent collaboration and teamworking skills across global functions.
• Proven people management capabilities.
• Strong business acumen, including financial and strategic awareness.

AstraZeneca is an equal opportunities employer. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

Overview

Join to apply for the Regulatory Affairs Specialist role at Smith+Nephew .

Life Unlimited. At Smith+Nephew, we design and manufacture technology that takes the limits off living.

The Regulatory Affairs Specialist is responsible for ensuring timely product registration and sustained regulatory compliance across the MENA region, with a focus on Saudi Arabia. This role supports business continuity by securing licenses, handling regulatory submissions, and maintaining positive relationships with local health authorities.

• Secure timely registration of new products in accordance with strategic plans.
• Ensure uninterrupted market access through proactive license renewals and tender documentation support.
• Monitor and interpret new and existing regulations, ensuring business alignment and readiness.
• Manage post-market regulatory activities and documentation to uphold compliance.
• Identify and mitigate regulatory risks impacting product lifecycle or market access.
• Maintain positive relationships with health authorities and regulatory bodies across the region.
• Collaborate cross-functionally with Global RA, distributors, and commercial teams to streamline regulatory processes.
• Support regulatory activities for import permits and tender submissions.
• Maintain and update central regulatory databases and product information systems.
• Contribute to the development of regional regulatory strategies in alignment with global objectives.

• Bachelor’s degree in Biomedical Engineering, Pharmacy, or a related field.
• Saudi Arabian nationality.
• Minimum 1 year of experience in regulatory affairs for medical devices.
• Consistent track record in regulatory submissions and compliance with regional health authority requirements.
• In-depth knowledge of SFDA regulations and MENA regional requirements.
• Familiarity with Quality Management System requirements in accordance with ISO 13485 and Good Distribution Practice (GDP).
• Strong understanding of post-market surveillance obligations.
• Experience with product registration and documentation for the KSA market.
• Proficient in English (written and spoken).

We believe in creating the greatest good for society. Our strongest investments are in our people and the patients we serve.

We are committed to welcoming, celebrating and thriving on diversity. Learn more about our Employee Inclusion Groups on our website.

Annual bonus, company stock saving plan.

Paid volunteering hours, flexible approach.

Employee Assistance Program.

Possibility of working in a hybrid model.

Hands-On, Team-Customized.

Referral bonus, recognition program, mentoring program.

Stay connected by joining our Talent Community. We are more than just a company — we are a community. Follow us on LinkedIn to see how we support and empower our employees and patients every day. Check us out on Glassdoor for a glimpse behind the scenes and a sneak peek into You. Unlimited. , life, culture, and benefits at S+N. Explore our website to learn more about our mission, our team, and the opportunities we offer.

• Seniority level: Associate
• Employment type: Full-time
• Job function: Project Management and Product Management
• Industries: Medical Equipment Manufacturing

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Responsibilities

• Prepare accurate and timely responses to SFDA inquiries in coordination with relevant departments, ensuring compliance with applicable regulations and deadlines.
• Review and analyze variations received from internal departments, determine their classification (major/minor), assess required documents, and prepare variation submissions in line with SFDA guidelines.
• Compile, validate, and submit eCTD (electronic Common Technical Document) dossiers for medicinal products and herbal/health supplements.
• Monitor and follow up on regulatory submissions, price appeals, inquiries, and variation statuses with SFDA to ensure process continuity and timely approvals.
• Ensure successful execution of the product registration plan, tracking milestones and collaborating with internal stakeholders to meet objectives.
• Maintain valid registration of all products in the market, ensuring that PILs (Patient Information Leaflets), SmPCs (Summary of Product Characteristics), and artworks are continuously updated and compliant.
• Act as the regulatory liaison for product life cycle activities, post-approval changes, and renewals to support product continuity in the KSA market.
• Stay abreast of changes in local regulations and provide strategic input to management on anticipated regulatory risks or opportunities.
• Develop and maintain strong relationships with SFDA officials and regulatory consultants to support proactive and smooth regulatory interactions.
• Support audits and inspections by ensuring readiness of regulatory documentation and compliance records.

• This position is open exclusively to Saudi nationals.
• Bachelor’s or master’s degree in pharmacy, Life Sciences, or a related field.
• Minimum 1–4 years of experience in Regulatory Affairs within the pharmaceutical or healthcare sector, with at least 1 years in the KSA market.
• Strong experience in SFDA submission processes and regulations.
• Hands-on experience with eCTD compilation and publishing.
• Proven track record in handling product variations, renewals, and regulatory compliance.
• Prior experience in managing or mentoring a small team is preferred.

Job Title: Regulatory Affairs Lead

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines for some of the world's most serious diseases.

Role Summary

The Regulatory Affairs Lead is responsible for driving regulatory strategies and managing submissions across the product lifecycle to ensure compliance with local and global requirements. The role provides expert advice on processes and documentation, proactively manages regulatory risks, and partners with health authorities and internal stakeholders to enable timely patient access to innovative medicines.

Responsibilities:

• Lead submission management and cross-functional teams for complex global regulatory applications, ensuring compliance with AstraZeneca's submission-ready standards.
• Provide regulatory expertise and strategic input to product and project teams, anticipating Health Authority requirements and guiding submissions-related activities.
• Identify potential regulatory risks to global and regional operational plans, proposing mitigation strategies.
• Implement and oversee strategies that improve the quality, efficiency, and timeliness of submissions.
• Manage processes related to product licenses, registrations, and post-marketing requirements, including labeling, safety reporting, inspections, and audits.
• Act as the primary regulatory contact with key authorities and ensure timely updates to global systems on regulatory guidelines, decrees, and communications.

Requirements:

• Saudi National
• Higher education in pharmaceuticals, medicine, or biotechnology.
• Minimum 9 years' experience in regulatory affairs, including at least 5 years in a multinational environment with proven contributions.
• Strong knowledge of local and international regulatory standards, requirements, and industry practices.
• Demonstrated ability to manage pivotal projects and resource requirements.
• Excellent collaboration and teamworking skills across global functions.
• Proven people management capabilities.
• Strong business acumen, including financial and strategic awareness.

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.

JOB TITLE

Regulatory Affairs Lead

ABOUT ASTRAZENECA

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines for some of the world's most serious diseases. But we're more than one of the world's leading pharmaceutical companies.

ROLE SUMMARY

The Regulatory Affairs Lead is responsible for driving regulatory strategies and managing submissions across the product lifecycle to ensure compliance with local and global requirements. The role provides expert advice on processes and documentation, proactively manages regulatory risks, and partners with health authorities and internal stakeholders to enable timely patient access to innovative medicines.

What you'll do

Regulatory Strategy & Submissions

• Lead submission management and cross-functional teams for complex global regulatory applications, ensuring compliance with AstraZeneca's submission-ready standards.
• Provide regulatory expertise and strategic input to product and project teams, anticipating Health Authority requirements and guiding submissions-related activities.
• Identify potential regulatory risks to global and regional operational plans, proposing mitigation strategies.
• Implement and oversee strategies that improve the quality, efficiency, and timeliness of submissions.
• Manage processes related to product licenses, registrations, and post-marketing requirements, including labeling, safety reporting, inspections, and audits.
• Act as the primary regulatory contact with key authorities (e.g., SFDA, GHC) and ensure timely updates to global systems on regulatory guidelines, decrees, and communications.

Business Partnering & Country RA Agenda

• Serve as the regulatory contact for the Country Head and Business Unit Directors (BUDs).
• Conduct regular meetings with local agents' regulatory teams to align on outstanding activities and ensure smooth execution.
• Foster alignment across therapy area RA managers, local agents, and global stakeholders on regulatory priorities.
• Represent AstraZeneca's regulatory interests in official engagements with authorities and industry forums.

Leadership & People Development

• Manage and develop a small team of regulatory professionals (1-2 direct reports), setting clear objectives, coaching, and providing growth opportunities.
• Promote a culture of collaboration, creativity, and courageous leadership across teams.
• Lead or participate in critical projects, ensuring regulatory business needs are integrated into AZ's systems, processes, and standards.

External Engagement & Business Awareness

• Build and maintain strong relationships with Regulatory Health Authorities, industry representatives, and key external partners.
• Monitor regulatory, policy, and industry dynamics, proactively advising internal stakeholders on potential impacts.
• Support business development activities, including proposals, reports, costing, and budgets, ensuring alignment with corporate strategy.

Governance & Compliance

• Ensure all regulatory activities adhere to AstraZeneca's Code of Ethics, corporate policies, and local legislation.
• Timely reporting of adverse events, compliance risks, conflicts of interest, and health/environment-related incidents.
• Provide regulatory input for audits, inspections, recalls, and related communications to minimize compliance risks.

Essential for the role

• Saudi National
• Higher education in pharmaceuticals, medicine, or biotechnology.
• Minimum 9 years' experience in regulatory affairs (drug development, product approval/launch, line extension, license maintenance, or Health Authority experience), including at least 5 years in a multinational environment with proven contributions.
• Strong knowledge of local and international regulatory standards, requirements, and industry practices.
• Demonstrated ability to manage pivotal projects and resource requirements.
• Excellent collaboration and teamworking skills across global functions.
• Proven people management capabilities.
• Strong business acumen, including financial and strategic awareness.

AstraZeneca is an equal opportunities employer. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

• Prepare accurate and timely responses to SFDA inquiries in coordination with relevant departments, ensuring compliance with applicable regulations and deadlines.
• Review and analyze variations received from internal departments, determine their classification (major/minor), assess required documents, and prepare variation submissions in line with SFDA guidelines.
• Compile, validate, and submit eCTD (electronic Common Technical Document) dossiers for medicinal products and herbal/health supplements.
• Monitor and follow up on regulatory submissions, price appeals, inquiries, and variation statuses with SFDA to ensure process continuity and timely approvals.
• Ensure successful execution of the product registration plan, tracking milestones and collaborating with internal stakeholders to meet objectives.
• Maintain valid registration of all products in the market, ensuring that PILs (Patient Information Leaflets), SmPCs (Summary of Product Characteristics), and artworks are continuously updated and compliant.
• Act as the regulatory liaison for product life cycle activities, post-approval changes, and renewals to support product continuity in the KSA market.
• Stay abreast of changes in local regulations and provide strategic input to management on anticipated regulatory risks or opportunities.
• Develop and maintain strong relationships with SFDA officials and regulatory consultants to support proactive and smooth regulatory interactions.
• Support audits and inspections by ensuring readiness of regulatory documentation and compliance records.

• This position is open exclusively to Saudi nationals.
• Bachelor's or master's degree in pharmacy, Life Sciences, or a related field.
• Minimum 1-4 years of experience in Regulatory Affairs within the pharmaceutical or healthcare sector, with at least 1 years in the KSA market.
• Strong experience in SFDA submission processes and regulations.
• Hands-on experience with eCTD compilation and publishing.
• Proven track record in handling product variations, renewals, and regulatory compliance.
• Prior experience in managing or mentoring a small team is preferred.