37 Regulatory Affairs jobs in Saudi Arabia

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.

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:

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

Responsibilities:

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

Preferred Candidate:

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

Skills

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

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

Responsibilities:

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

Preferred Candidate:

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

Skills

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

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

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

Additional Job Description:

Primary Location:

Job Posting Date:

Job Type:

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

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

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

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

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.

What will you be doing?

• 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.

What will you need to be successful?

• Bachelor's degree in Biomedical Engineering, Pharmacy, or a related
• 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)

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

Inclusion and Belonging:
committed to welcoming, celebrating and thriving on diversity, learn more about our Employee Inclusion Groups on our website

Your Future:
annual bonus, company stock saving plan

Work/Life Balance:
paid volunteering hours, flexible approach

Your Wellbeing:
Employee Assistance Program

Flexibility:
possibility of working in hybrid model

Training:
Hands-On, Team-Customized

Extra Perks:
referral bonus, recognition program, mentoring program

Stay connected by joining our Talent Community.

We're more than just a company - we're 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 and learn more about our mission, our team, and the opportunities we offer.

Date posted: Sep 10, 2025

City: Riyadh

Country/Region: SA

Type of Contract: Full-time Employment / Unlimited

Job Requisition ID: 9758

Regulatory Affairs Specialist - KSA

Job Purpose

• The Regulatory Affairs Specialist focuses on ensuring that the organization meets all of the applicable regulations. Their goal is to ensure that new products meet certain requirements as set by Health Authorities.
• Regulatory Affairs Specialist ME is responsible for Saudi Arabia activities (KSA).
• Identifying all elements and actions necessary for registering and maintaining valid marketing authorizations in KSA.
• Collaboration with the local partners, local authorities and WRA in France.
• Coordinate and document internal regulatory processes, such as internal audits, inspections, license renewals or registrations.
• Handle registrations of new products/sites/medical devices, pricing as well as maintaining life cycle of products in KSA, including renewals and variations.
• Ensure that all relevant regulations are fully met in dossiers, with the aim of complying with the requirements established by Health Authorities.
• Collaborates closely with the Department Head in all department related tasks and activities.
• Compile and prepare new products and manufacturing sites registration files for submissions to authorities in KSA as per Regulatory timelines.
• Cross functionality & collaboration with Global teams as well as all ME departments, provide regulatory support and guidance whenever required.

Role Responsibilities
Life-Cycle
management of products

• Pre-registration coordination with WRA and preparation of documentation for KSA to compile the product and manufacturing site files, Review/ Preparation/Submission of dossiers, fees, inquiries, answers to questions, approvals.
• Life-cycle management of products that includes new registrations, renewals/minor variation of both products and sites.
• Follow country specific procedures and SFDA guidelines in the KSA market.
• Coordination & liaising with WRA teams/distributors for preparation of all types of regulatory dossiers & local documentation.
• Preparation of price forms and related documentation for new product registration files.
• Liaising with WRA, agents and authorities for documentation submission and follow-up and keep track.
• To keep track of the registration status of products with submission, registration, expiry dates.

Regulatory Tasks

• Closely collaborate with the Head of the Department for all regulatory tasks.
• Monthly Reports, Correspondences/Mails, Scientific Office Renewal at the SFDA.
• Involved actively in the budget preparation of KSA Regulatory Affairs.
• Follow-up on regulatory guidelines and ensure sharing of regulatory information with all concerned.
• Reference standard submissions to the authorities.
• Helping the Supply Chain Department for tenders - preparation of documentation for institutional tender submissions.
• Actively involved in Regulatory Audits.

Regulatory Site Management

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

Other Related Tasks

• Management/Organizing department supported conferences for Health Authorities in the ME countries.
• Liaise closely with agent and Health Authorities in KSA.
• Responsible for Change Controls for Variations for the ME region.
• Work as a deputy for the local responsible person for advertisement/promotional material.
• Deputy Local Responsible person for validation of Packaging Items.
• Cross collaboration with other ME departments.

Dimensions

• Geographical span: ME - KSA.
• Work with the ME Regulatory Lead to develop a detailed understanding of regulatory guidelines and technical requirements in KSA.
• Life cycle management of products, understanding of industry-specific regulations, audit procedures, and the ability to ensure compliance with regulatory standards.
• Work and support the KSA Regulatory Affairs team.
• Cross-functionality with other departments.
• Report to the Head of the Department.

Requirements
Educational
qualifications

• Bachelor's Degree in Pharmacy / Science.

Relevant Experience

• 3+ years of relevant pharmaceutical regulatory experience within a large multinational organization.
• Experience working in Saudi Arabia (preferred).
• Experience of working within a Global pharmaceutical company would be an advantage.

Skills & Personal Characteristics

• Good knowledge of the Regulatory environment and procedures in KSA.
• Sharp Regulatory Intelligence.
• Ability to work cross functional to resolve complex issues.
• Strategic thinker, innovative, able to drive multiple-simultaneous initiatives, able to work under pressure, team player.
• Multi-tasking, organized, Process & Result oriented, Focused, Problem solving, good judgment and decision-making capability.
• Excellent interpersonal, Negotiation and relationship building skills.
• Excellent interpersonal, communication & digital skills.
• Written and spoken fluency in English & Arabic (French is an added advantage).

Whatever your area of expertise, your work within the Servier Group helps advance therapeutic progress for the benefit of patients. You will be part of teams recognized for their scientific excellence and reach your full potential in a professional environment that encourages you to develop yourself. Tailor-made onboarding journeys, mobility opportunities, quality trainings, responsible management, team spirit. All this and more in a workplace focused on your well-being.

At Servier, we are committed to therapeutic progress to serve patient needs. We put the diversity of our employees as a source of richness for the fulfillment of this vocation.

Date posted: Sep 10, 2025

City: Riyadh

Country/Region: SA

Type of Contract: Full-time Employment / Unlimited

Job Requisition ID: 9758

Regulatory Affairs Specialist - KSA

.

Job Purpose

• The Regulatory Affairs Specialist focuses on ensuring that the organization meets all of the applicable regulations. Their goal is to ensure that new products meet certain requirements as set by Health Authorities.
• Regulatory Affairs Specialist ME is responsible for Saudi Arabia activities (KSA).
• Identifying all elements and actions necessary for registering and maintaining valid marketing authorizations in KSA.
• Collaboration with the local partners, local authorities and WRA in France.
• Coordinate and document internal regulatory processes, such as internal audits, inspections, license renewals or registrations.
• Handle registrations of new products/sites/medical devices, pricing as well as maintaining life cycle of products in KSA, including renewals and variations.
• Ensure that all relevant regulations are fully met in dossiers, with the aim of complying with the requirements established by Health Authorities.
• Collaborates closely with the Department Head in all department related tasks and activities.
• Compile and prepare new products and manufacturing sites registration files for submissions to authorities in KSA as per Regulatory timelines.
• Cross functionality & collaboration with Global teams as well as all ME departments, provide regulatory support and guidance whenever required.

Role Responsibilities

Life-Cycle management of products

• Pre-registration coordination with WRA and preparation of documentation for KSA to compile the product and manufacturing site files, Review/ Preparation/Submission of dossiers, fees, inquiries, answers to questions, approvals.
• Life-cycle management of products that includes new registrations, renewals/minor variation of both products and sites.
• Follow country specific procedures and SFDA guidelines in the KSA market.
• Coordination & liaising with WRA teams/distributors for preparation of all types of regulatory dossiers & local documentation.
• Preparation of price forms and related documentation for new product registration files.
• Liaising with WRA, agents and authorities for documentation submission and follow-up and keep track.
• To keep track of the registration status of products with submission, registration, expiry dates.

Regulatory Tasks

• Closely collaborate with the Head of the Department for all regulatory tasks.
• Monthly Reports, Correspondences/Mails, Scientific Office Renewal at the SFDA.
• Involved actively in the budget preparation of KSA Regulatory Affairs.
• Follow-up on regulatory guidelines and ensure sharing of regulatory information with all concerned.
• Reference standard submissions to the authorities.
• Helping the Supply Chain Department for tenders - preparation of documentation for institutional tender submissions.
• Actively involved in Regulatory Audits.

Regulatory Site Management

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

Other related tasks

• Management/Organizing department supported conferences for Health Authorities in the ME countries.
• Liaise closely with agent and Health Authorities in KSA.
• Responsible for Change Controls for Variations for the ME region.
• Work as a deputy for the local responsible person for advertisement/promotional material.
• Deputy Local Responsible person for validation of Packaging Items.
• Cross collaboration with other ME departments.

Dimensions

• Geographical span: ME - KSA.
• Work with the ME Regulatory Lead to develop a detailed understanding of regulatory guidelines and technical requirements in KSA.
• Life cycle management of products, understanding of industry-specific regulations, audit procedures, and the ability to ensure compliance with regulatory standards.
• Work and support the KSA Regulatory Affairs team.
• Cross-functionality with other departments.
• Report to the Head of the Department.

Requirements

Educationalqualifications

• Bachelor's Degree in Pharmacy / Science.

Relevant Experience

• 3+ years of relevant pharmaceutical regulatory experience within a large multinational organization.
• Experience working in Saudi Arabia (preferred).
• Experience of working within a Global pharmaceutical company would be an advantage.

Skills & Personal characteristics

• Good knowledge of the Regulatory environment and procedures in KSA.
• Sharp Regulatory Intelligence.
• Ability to work cross functional to resolve complex issues.
• Strategic thinker, innovative, able to drive multiple-simultaneous initiatives, able to work under pressure, team player.
• Multi-tasking, organized, Process & Result oriented, Focused, Problem solving, good judgment and decision-making capability.
• Excellent interpersonal, Negotiation and relationship building skills.
• Excellent interpersonal, communication & digital skills.
• Written and spoken fluency in English & Arabic (French is an added advantage).

Whatever your area of expertise, your work within the Servier Group helps advance therapeutic progress for the benefit of patients. You will be part of teams recognized for their scientific excellence and reach your full potential in a professional environment that encourages you to develop yourself. Tailor-made onboarding journeys, mobility opportunities, quality trainings, responsible management, team spirit. All this and more in a workplace focused on your well-being.

At Servier, we are committed to therapeutic progress to serve patient needs. We put the diversity of our employees as a source of richness for the fulfillment of this vocation.