56 Regulatory Affairs 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.

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.

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.

• 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.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at

Job Function:

Regulatory Affairs Group

Job Sub Function:

Regulatory Product Submissions and Registration

Job Category:

Professional

All Job Posting Locations:

Riyadh, Saudi Arabia

Job Description:

About MedTech

Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments.

Your unique talents will help patients on their journey to wellness. Learn more at

REGULATORY AFFAIRS SPECIALIST (MEDICAL DEVICES)

Location: Riyadh

Contract: full-time

Purpose:

The main task of a Regulatory Affairs specialist in Johnson & Johnson is Launching of Medical Device Products in Saudi Arabia Market in compliance with the Regulatory registration & importation guidance.

You will be responsible for:

• Preparing, compiling and submission of registration/ re-registration products files in addition to variation submission on time directly in Saudi Arabia or through J&J distributors when applicable
• SFDA meetings
• Clearance support to distributors
• Updating the regulatory tracking systems
• Having the renewed certificates & re-registration licenses of expired ones on time
• Responding to Change Impact Assessments before due dates
• Doing Copy Review process for promotional materials on time upon request
• Lift all regulatory restrictions for products that can be shipped to Saudi Arabia
• Tender support to commercial teams & distributors

Qualifications / Requirements:

• Education: Bachelor's (B.Sc.) degree of Biomedical engineering or Sciences
• Minimum 2 years of Regulatory Affairs experience withing Medical Devices industry
• Language: English & Arabic (fluent)
• Time Management
• Very good presentation & communication skills
• Sense of urgency, attention to details, creative problem-solving
• Collaboration & teamwork
• Self-motivation, ability to work under stress
• Involvement in Regional Projects
• Saudi national

California Greens Corp. is a leading pharmaceutical and nutraceutical manufacturer with headquarters in New Jersey, USA, and a state-of-the-art production facility in Sudair City for Industry and Businesses, Saudi Arabia. We are committed to delivering high-quality products across the MENA region.

About the Job:

• Job Title : Regulatory Affairs Specialist

• Job Location : Riyadh, Saudi Arabia

• Working hours : Full time

• Benefits : Attractive package based on experience/ Medical insurance

• Application duration: Till 07 / 08 / 2025

Job Responsibilities

• Lead and manage all Regulatory Affairs activities in Saudi Arabia and the MENA region.

• Coordinate product registration processes in collaboration with local agents and regulatory authorities.

• Liaise with the Saudi Food and Drug Authority (SFDA) and other regional regulatory bodies to monitor, follow up, and expedite product (SKU) registrations.

• Respond to regulatory inquiries and ensure the timely resolution of any issues raised by authorities.

• Prepare, review, and submit regulatory dossiers and documentation in full compliance with local and regional requirements.

Required Qualifications

• Bachelor's degree in a scientific or medical field (Pharmacy, Chemistry, Biology).

• Minimum of 3 years of hands-on experience in Regulatory Affairs, specifically with SFDA) within the pharmaceutical or nutraceutical sector.

• Strong understanding and practical knowledge of SFDA, GCC, and MENA regulatory frameworks and guidelines.

• Proficiency in Microsoft Office Suite and regulatory submission platforms.

Personal Skills

• Fluency in both English and Arabic (written and spoken) is essential.

• Teamwork spirit

• Time management

• Problem solving

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at

Job Function
Regulatory Affairs Group

Job Sub Function
Regulatory Product Submissions and Registration

Job Category
Professional

All Job Posting Locations:
Riyadh, Saudi Arabia

Job Description
About MedTech
Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments.

Your unique talents will help patients on their journey to wellness. Learn more at

REGULATORY AFFAIRS SPECIALIST (MEDICAL DEVICES)
Location: Riyadh
Contract: full-time
Purpose
The main task of a Regulatory Affairs specialist in Johnson & Johnson is Launching of Medical Device Products in Saudi Arabia Market in compliance with the Regulatory registration & importation guidance.

You Will Be Responsible For

• Preparing, compiling and submission of registration/ re-registration products files in addition to variation submission on time directly in Saudi Arabia or through J&J distributors when applicable
• SFDA meetings
• Clearance support to distributors
• Updating the regulatory tracking systems
• Having the renewed certificates & re-registration licenses of expired ones on time
• Responding to Change Impact Assessments before due dates
• Doing Copy Review process for promotional materials on time upon request
• Lift all regulatory restrictions for products that can be shipped to Saudi Arabia
• Tender support to commercial teams & distributors

Qualifications / Requirements

• Education: Bachelor's (B.Sc.) degree of Biomedical engineering or Sciences
• Minimum 2 years of Regulatory Affairs experience withing Medical Devices industry
• Language: English & Arabic (fluent)
• Time Management
• Very good presentation & communication skills
• Sense of urgency, attention to details, creative problem-solving
• Collaboration & teamwork
• Self-motivation, ability to work under stress
• Involvement in Regional Projects
• Saudi national

Roles and Responsibilities

• Support registration processes with regulatory bodies within Saudi Arabia, for IVDs and medical devices.
• Internal and external communication to complete registration requirements.
• Update trackers and internal files for visibility of all regulatory processes.
• Support with inbound shipment regulatory operations and related communications.
• Preparation of regulatory letters and templates.

Qualifications

• Bachelor's Degree in Medical Laboratory Sciences, Biomedical Engineering or Biomedical Technology.
• High written and verbal communication skills in Arabic and English.
• Good MS Office Skills.
• Tamheer conditions apply.
• No experience required.

About Sysmex LLC

Sysmex Corporation supports healthcare professionals around the world in lighting the way with diagnostics by providing a broad range of medical diagnostic products and solutions. In the fields of Haematology, urinalysis, hemostasis, life science, flow cytometry, essential healthcare and immunochemistry, we combine highly dependable, multi-functional and easy-to-operate instruments, a variety of reagents and software, plus reliable service and support.

Sysmex LLC, located in Riyadh, Saudi Arabia, is a subsidiary of the Sysmex Corporation from Kobe, Japan. From our Riyadh offices, we serve our customers in Saudi Arabia and support healthcare professionals by providing medical diagnostic products, solutions and services.

International Reputation

Sysmex ranks among the top diagnostic companies, being a world leader in haematology diagnostics and services. Globally, the company operates in more than 190 countries and regions around the world and employs more than 10,000 people.

The company's net sales at the fiscal year ended March 2022 were 2.79 € billion (¥363.7 billion: €1=¥130), with the EMEA region accounting for 27.9% of that amount.