62 Regulatory Affairs Manager jobs in Saudi Arabia

Leverage your abilities and join a leading medical device manufacturer driving compliance and innovation across Saudi Arabia.

The Regulatory Affairs Manager ensures all medical devices comply with SFDA and international standards by managing product registrations, renewals, and documentation.

• Prepare, review, and submit regulatory files, technical documentation, and ESTD to SFDA.
• Manage communication with SFDA authorities for product approvals and renewals.
• Track and interpret new regulations impacting medical device compliance.
• Maintain product registration database and ensure documentation accuracy.
• Collaborate with QA, R&D, and Production to ensure regulatory alignment.

• Bachelor's degree in Pharmacy, Biomedical Engineering, or Science.
• 8+ years of experience in Regulatory Affairs for medical devices.
• Solid knowledge of SFDA requirements, ISO 13485, and MDSAP.
• Strong documentation and submission management skills.
• Excellent English communication.

Job Scope

Regulatory Affairs Manager to oversee and manage all regulatory activities for pharmaceutical products in the Kingdom of Saudi Arabia. The role ensures full compliance with SFDA regulations and supports business growth by securing timely approvals and renewals for our portfolio.

Job Responsibilities

• Manage product registration, renewal, and variations with the SFDA.
• Ensure compliance with SFDA guidelines covering pricing, labeling, and packaging.
• Prepare, review, and submit complete regulatory dossiers.
• Liaise with SFDA officials to resolve queries and secure approvals.
• Monitor changes in KSA pharmaceutical regulations and update management on implications. Support B2B partnerships by providing regulatory expertise for new product launches.
• Maintain accurate regulatory documentation for audits and inspections.
• Provide training and guidance to internal teams on SFDA compliance processes.

Requirements

• Bachelor's degree in Pharmacy (BPharm) is mandatory (Master's preferred).
• 7+ years of regulatory affairs experience in the pharmaceutical industry, including strong exposure to the KSA market.
• Proven record of successful SFDA product registrations and renewals.
• Deep knowledge of KSA pharmaceutical laws, pricing policies, and compliance frameworks.
• Strong communication and stakeholder management skills.
• Fluency in English & Arabic

Wil je een cruciale rol spelen in het waarborgen en verder professionaliseren van kwaliteitsstandaarden binnen een toonaangevend, internationaal familiebedrijf in de medische sector?

Over de rol

Als Quality Manager ben je de drijvende kracht achter het kwaliteitsbeleid en het geweten van de organisatie. Je stuurt een divers team van 11 kwaliteitsmedewerkers aan, verspreid over verschillende locaties, en inspireert hen in hun persoonlijke en professionele ontwikkeling.

De brede scope vraagt om een strategische denker die zich kan navigeren door de complexiteit van een internationale organisatie, terwijl de focus op continue verbetering en operationele excellentie behouden blijft.

Jouw Verantwoordelijkheden

Jij bent de architect van vooruitgang, waarbij je het Quality team inspireert en de koers uitzet voor een toekomstbestendig kwaliteitsbeleid. Jouw visie tilt de organisatie naar een hoger niveau en zorgt voor zichtbaar succes, zowel intern als extern.

• Leiderschap en Teamontwikkeling

: Jij stimuleert de persoonlijke groei en expertiseontwikkeling van het Quality team, verspreid over diverse locaties. Je verenigt en inspireert hen tot een proactieve, samenwerkende partner binnen de gehele organisatie.
- Strategische Inrichting van het KMS

: Je definieert en waarborgt een robuust Kwaliteitsmanagementsysteem (KMS) dat voldoet aan de hoogste GxP-richtlijnen en ISO 13485-standaarden.
- Kwaliteitsborging en Procesoptimalisatie

: Je overziet de correctheid en kwaliteit van essentiële documentatie en operationele processen, met een scherp oog voor continue verbetering.
- Crisismanagement en Reputatiebeheer

: Je bent eindverantwoordelijk voor de coördinatie van product recall operaties en de effectieve afhandeling van complexe klant- en patiëntklachten.
- Relatiemanagement en Contractevaluatie

: Jij bepaalt de kaders voor de kwalificatie van leveranciers en klanten, en evalueert contracten voor de distributie en het transport van medische producten.
- Autoriteit in Audits en Inspecties

: Je draagt de eindverantwoordelijkheid voor de strategie rondom interne audits en het succesvol managen van externe audits en inspecties door regelgevende instanties zoals FAGG en IGJ.
- Besluitvorming en Productconformiteit

: Jij neemt cruciale beslissingen over quarantaine, vernietiging en de vrijgave van producten voor verkoop, waarbij je altijd de productconformiteit vooropstelt.
- Informatievoorziening en Compliance Cultuur

: Je rapporteert over de effectiviteit van het KMS en initieert bewustwording programma's om een diepgaand begrip van wettelijke vereisten binnen de organisatie te borgen

Het Kwaliteitsteam

Het team van 11 professionals is momenteel verspreid over verschillende locaties. Ze zoeken een leider die dit team kan verenigen en inspireren. Er is behoefte aan innovatie en een transitie naar een cultuur waarin het team als samenwerkingspartner van verschillende afdelingen handelt. Jouw taak is om het team als een proactieve en faciliterende partner binnen de organisatie neer te zetten.

Functie-eisen

• Opleiding: Hogere afgeronde opleiding, wo werk- en denkniveau.
• Ervaring: Ruime ervaring in een leidinggevende kwaliteitsrol, bij voorkeur in de medische hulpmiddelen en/of farmaceutische industrie.
• Persoonlijkheid: Je bent het 'geweten van de organisatie', beschikt over uitstekende organisatie sensitiviteit. Je bent een verbinder, een 'bouwer' die in staat is verbeteringen door te voeren en teams op te bouwen. Je werkt gestructureerd en bent in staat de afdeling naar een hoger niveau te tillen. Je bent communicatief sterk en in staat om een cultuur van continue verbetering te stimuleren.
• Kennis: kennis van , ISO 13485, MDR 2017/745 en relevante GxP-richtlijnen is essentieel. Ervaring met regelgevende zaken (RA), GDP, vigilantie en VCA is een plus.
• Taal: Zowel mondelinge als schriftelijke uitdrukkingsvaardigheid in de Engelse taal is een vereiste
• RP is een plus

Arbeidsvoorwaarden

Naast een uitdagende en impactvolle functie binnen een ambitieuze organisatie, bieden wij:

• Een competitief salaris.
• Een fulltime dienstverband (40 uur per week) met 26 vakantiedagen en 13 ADV-dagen.
• Een premievrije pensioenregeling.
• Thuiswerkvergoeding van en een onkostenvergoeding.
• Auto van de zaak
• Een aantrekkelijk bonussysteem en aanvullende verzekeringen via de werkgever.
• Volop ontwikkel- en opleidingsmogelijkheden om jouw expertise verder te verdiepen.
• Regelmatige teamactiviteiten en een prettige werksfeer.
• Mogelijkheden voor hybride werken en flexibele werktijden.

Leverage your abilities and join a leading medical device manufacturer driving compliance and innovation across Saudi Arabia.

The Regulatory Affairs Manager ensures all medical devices comply with SFDA and international standards by managing product registrations, renewals, and documentation.

• Prepare, review, and submit regulatory files, technical documentation, and ESTD to SFDA.

• Manage communication with SFDA authorities for product approvals and renewals.

• Track and interpret new regulations impacting medical device compliance.

• Maintain product registration database and ensure documentation accuracy.

• Collaborate with QA, R&D, and Production to ensure regulatory alignment.

• Bachelor’s degree in Pharmacy, Biomedical Engineering, or Science.

• 8+ years of experience in Regulatory Affairs for medical devices.

• Solid knowledge of SFDA requirements, ISO 13485, and MDSAP.

• Strong documentation and submission management skills.

• Excellent English communication.

Leverage your abilities and join a leading medical device manufacturer driving compliance and innovation across Saudi Arabia.

The Regulatory Affairs Manager ensures all medical devices comply with SFDA and international standards by managing product registrations, renewals, and documentation.

• Prepare, review, and submit regulatory files, technical documentation, and ESTD to SFDA.

• Manage communication with SFDA authorities for product approvals and renewals.

• Track and interpret new regulations impacting medical device compliance.

• Maintain product registration database and ensure documentation accuracy.

• Collaborate with QA, R&D, and Production to ensure regulatory alignment.

• Bachelor’s degree in Pharmacy, Biomedical Engineering, or Science.

• 8+ years of experience in Regulatory Affairs for medical devices.

• Solid knowledge of SFDA requirements, ISO 13485, and MDSAP.

• Strong documentation and submission management skills.

• Excellent English communication.

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 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.

• 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.

• 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

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

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.

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

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.

Primary Location: SA Riyadh

Job Posting Date:

Job Type: Permanent

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:

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:

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 .

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:

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:

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 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.

• 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.

• 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

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

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.

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 .

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.

Primary Location: SA Riyadh

Job Posting Date:

Job Type: Permanent