Regulatory Affairs Specialist

GSK Saudi Arabia is committed to supporting Vision 2030 and the Saudi Arabian National Agenda including Saudization in line with the hiring and the training and development of Saudi National capability. ​

Role overview
We are seeking a Regulatory Affairs Officer to support SFDA submissions, lifecycle management, labelling and cross‑functional regulatory activities for locally marketed and globally supplied products. This is an in‑office role based in Riyadh and involves close coordination with global RA teams, local site QA/RA contacts, commercial, medical, supply and external partners.

Key responsibilities

• Prepare, submit and follow up SFDA applications for new products, renewals and variations in line with global submission strategies
• Maintain product licenses and manage timelines for renewals, changes and variations
• Coordinate and review regulatory labelling and packaging (including Arabic translations) to ensure SFDA compliance
• Support regulatory projects and liaise with global and local stakeholders to deliver required RA activities
• Coordinate locally manufactured product changes with site RA and quality teams
• Monitor SFDA and regional regulatory updates; assess impact and communicate to stakeholders
• Serve as primary RA contact for internal teams and external agents/distributors; represent GSK in regulatory meetings as needed
• Maintain regulatory tracking dashboards and audit‑ready documentation, support health authority inspections
• Communicate with SFDA via approved channels and arrange meetings with relevant SFDA departments when necessary
• Provide cross‑functional regulatory support for tender submissions, promotional material approvals and product supply strategyEssential qualifications & experience

• Bachelor’s degree in pharmacy, Pharmaceutical Sciences or related life sciences field
• 1–3 years’ Regulatory Affairs experience in a multinational pharmaceutical company, with strong exposure to SFDA submissions and Saudi market requirements
• Fluent in Arabic and English (written and spoken)
• Deep understanding of SFDA regulations, eCTD requirements, labelling standards and regulatory lifecycle management
• Strong organizational, project coordination and communication skills; ability to manage multiple priorities under tight timelines
• Demonstrated experience implementing regulatory change and SOPs consistent with global/local RA frameworks
• Strong stakeholder engagement and negotiation skillsMandatory

• Saudi national
• Saudi‑licensed pharmacistNice to have

• Exposure to price negotiation or pricing appeals with SFDA
• Experience liaising with scientific office or providing pharmacovigilance oversightWork Environment
This role is based in Riyadh, Saudi Arabia.

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.

Why GSK?
Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

Contact information:
You may apply for this position online by selecting the Apply now button.

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