30 Regulatory Affairs jobs in Saudi Arabia

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:

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

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

Additional Job Description:

Primary Location:

Job Posting Date:

Job Type:

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

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

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

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

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

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

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

Designation: Regulatory Affair Senior Officer

Department: Scientific Office / Riyadh K.S.A

Summary Of Responsibilities

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

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

• Bachelor of Pharmacy.
  
  

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

• Seniority level Mid-Senior level

• Employment type Full-time

• Job function Legal
• Industries Pharmaceutical Manufacturing

Referrals increase your chances of interviewing at Julphar by 2x

Riyadh, Riyadh, Saudi Arabia 22 hours ago

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RA Specialist will fulfill the local regulatory activities to maintain & keep the RA portfolio compliant for KSA ( 70 % ) and rest of ME markets ( 30%) . He / she will support RA manager on operational RA submissions to allow the RA managers in UAE & KSA to focus on critical projects Relfydess & Nemluvio . In addition , RA manager in KSA needs to focus on enhancing external engagement with Health authority & local trade association that is identified as a major gap currently. RA Specialist will ensure business continuity and serve as a back up for RA manager in KSA for RA in addition to serving as a back up for QA & PV , considering that RA , QA & PV are mandatory functions to be always available on site .Provide strategic and operational RA support for Saudi to ensure on time renewal, maintenance , variations of existing & new products for IA, TD, DS including mandatory regulatory. It is critical to maintain momentum to ensure compliance to constantly evolving SFDA guidelines

Duties & Responsibilities

Manage the entire registration process in ensuring approvals of new products and amendments to products

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

Stay abreast of - and ensure compliance with - the continuously evolving (complex & country specific) regulatory framework in KSA & rest of ME markets

Ensure compliance with, and maintenance of, existing product licenses.

Ensure high quality and timely submissions, support in enhancing regulatory intelligence , create & maintain database for simplifying local RA processes of record retention , regulatory submission tracking

Ensure that progress of applications and changes to registered details are communicated to local and global stakeholders, as appropriate

Manage in-house regulatory files, documentation and Corporate electronic databases. With the LE set up in Saudi the responsibilities & accountability of RA manager in front of Saudi HA ( SFDA ) have increased requiring more time & focus from RA manager to engage with external stakeholders & ensure compliance at all time for all regulated TD,IA,DS portfolio. RA specialist is critical to ensure compliance to ongoing RA activities , serve as back up for RA / QA/PV and allow RA to focus on critical submissions ongoing & to be made for Relfydess & Nemluvio to enable timely registrations . RA specialist will also support projects that need improvement in process enhancement & simplification tools for all ME markets , such as tracking tools , data management & also internalize some of the RA activities that are currently outsourced such as eCTD preparation in a phased manner

Saudi Arabia national and MOH licensed pharmacist

Minimum 4-5 years experience in a similar Regulatory affairs role in the field of prescription medicinal products and medical devices in Saudi Arabia & UAE

In-depth understanding of the pharmaceutical industry within Saudi Arabia, and strong connections with SFDA will be preferred

Quality experience & fair knowledge of Pharmacovigilance preferred.

Computer literate, familiar with Computer based information systems, and new

Electronic documentation systems.

Fluency in written and verbal English and Arabic

What we offer in return

You will be working for an organization that embraces diversity & inclusion and believe we will deliver better outcomes by reflecting the perspectives of our diverse customer base.

You will receive a competitive compensation package with bonus structure and extended benefit package.

You will be joining a growing company that believes in ownership from day one where everyone is empowered to grow and to take accountability.

Next Step

Please apply with an English language CV.

If your profile is a match, we will invite you for a first virtual conversation with the recruiter.

The next step is a virtual conversation with the hiring manager.

The final step is a panel conversation with the extended team.

Company Industry

• Pharma
• Biotech
• Clinical Research

Department / Functional Area

• Administration

Keywords

• Regulatory Affairs Specialist KSA

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Join to apply for the Regulatory Affairs Specialist KSA role at Galderma .

Galderma is the emerging pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare, and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body's largest organ - the skin - meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand the skin, we are shaping our lives, and we are advancing dermatology for every skin story.

We look for people who focus on results, embrace learning, and bring positive energy. They must combine initiative with teamwork and collaboration. Above all, they must be passionate about making a meaningful impact for consumers, patients, and healthcare professionals. We aim to empower employees and promote personal growth while meeting business needs now and in the future. We embrace diversity and respect the dignity, privacy, and personal rights of every employee.

At Galderma, we are committed to becoming the leading dermatology company in the world. Join us to gain new experiences and create an impact.

Location: KSA, Riyadh

The RA Specialist will manage local regulatory activities to ensure compliance for KSA (70%) and UAE (30%). They will support the RA manager in operational submissions, ensure compliance with all RA and SO responsibilities, and be prepared for audits by HA. The role includes ensuring business continuity, serving as a backup for the RA manager in KSA, and supporting QA and PV functions. The specialist will provide strategic and operational support for product renewals, maintenance, and variations, maintaining momentum to comply with SFDA guidelines.

• Manage registration processes for new products and amendments
• Develop and execute registration strategies in collaboration with Global and local RA teams
• Ensure compliance with evolving regulatory frameworks in KSA and UAE
• Maintain existing product licenses
• Support high-quality and timely submissions; enhance regulatory intelligence; maintain databases for record retention and submission tracking
• Communicate application progress to stakeholders
• Manage regulatory files and documentation; support process improvements and internalize outsourced activities

• Pharmacist or Pharmaceutical Sciences degree
• Saudi MOH license and Saudi nationality
• 4-5 years' experience in regulatory affairs related to medicinal products and medical devices in Saudi Arabia & UAE
• Strong understanding of the pharmaceutical industry and SFDA connections preferred
• Knowledge of Pharmacovigilance and quality systems preferred
• Computer literacy and familiarity with electronic documentation systems
• Fluent in English and Arabic, both written and verbal

• Inclusive work environment embracing diversity
• Competitive compensation, bonus, and benefits
• Growth opportunities with ownership from day one

• Apply with an English CV
• If shortlisted, participate in virtual interviews with recruiter, hiring manager, and team panels

• Seniority level: Mid-Senior
• Employment type: Full-time
• Job function: Legal
• Industry: Pharmaceutical Manufacturing

The Director – Airport Regulatory Affairs is responsible for leading the development, implementation, and oversight of regulatory strategies and compliance frameworks that align with national and international aviation standards. This role acts as the primary interface with civil aviation authorities, government bodies, and international regulatory agencies , ensuring the airport operates in full compliance while shaping and influencing policy that supports long-term strategic objectives.

Key Responsibilities:

Regulatory Strategy & Compliance

• Develop and implement a comprehensive regulatory affairs strategy aligned with the airport’s long-term vision and growth plans.
• Monitor and interpret existing and emerging aviation laws, regulations, and policies (ICAO, IATA, national civil aviation regulations).
• Ensure ongoing compliance with airside, landside, environmental, safety, and security regulations applicable to airport operations and infrastructure.

Stakeholder Engagement & Representation

• Serve as the lead liaison with regulatory bodies, including the Civil Aviation Authority , Ministry of Transport , environmental agencies, customs, and border control.
• Represent the airport in regulatory hearings, consultations, and industry working groups , both domestically and internationally.
• Build strategic alliances and influence regulatory policy to support airport development and innovation.
• Work with the Strategy division to evaluate regulatory risks and opportunities that may impact current or future airport projects.
• Draft formal policy positions, white papers, and briefing notes to support regulatory engagement or lobby for favorable regulatory changes.
• Lead internal alignment on regulatory requirements during project planning , including master planning, airspace design, and sustainability initiatives.

Licensing, Permits & Approvals

• Oversee the licensing and certification process for the airport and key facilities in collaboration with operational units.
• Ensure all necessary permits, certifications, and regulatory submissions are obtained and renewed in a timely manner.
• Establish internal governance frameworks and reporting structures to monitor compliance with aviation and regulatory policies.
• Provide regular updates and risk assessments to the executive leadership team on regulatory developments.
• Prepare board-level reports and strategy input related to regulatory affairs.
• Work with legal, operations, environment, safety, security, and planning teams to integrate regulatory requirements into all aspects of airport development and operations.
• Ensure alignment with ESG , sustainability, and resilience frameworks from a regulatory standpoint.

Qualifications & Experience:

• Bachelor’s degree in Law, Public Policy, Aviation Management, Engineering , or related field
• Master’s degree (e.g., LLM, MPA, MBA, or MSc in Aviation ) is strongly preferred
• Minimum 8 years of experience in aviation regulatory affairs, public policy, legal compliance , or related fields
• At least 3 years in a senior leadership or advisory capacity
• Proven experience engaging with civil aviation regulators, international agencies (ICAO, IATA) , and government institutions
• Prior involvement in airport development, certification, or expansion programs is a strong advantage

• Seniority level Director

• Employment type Full-time

• Job function Other
• Industries Airlines and Aviation

Referrals increase your chances of interviewing at King Salman International Airport Development Company by 2x

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Overview

Join to apply for the Regulatory Affairs TSO Manager KSA role at Mundipharma .

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 meetings 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 focusing 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.