Regulatory Affairs Specialist – Saudi Arabia

About the role

Galderma is seeking a Regulatory Affairs Specialist to manage local regulatory activities for Saudi Arabia and the United Arab Emirates. The role supports the RA Manager in maintaining compliance of the product portfolio, ensuring readiness for audits, and providing continuity for Quality Assurance and Pharmacovigilance functions.

Key responsibilities

• Manage the full registration process for new products and product amendments, covering prescription medicines, injectable aesthetics, medical devices, and cosmetics.
• Develop and execute registration strategies in collaboration with Global RA and local teams.
• Support the RA Manager with operational submissions and maintain continuous compliance with SFDA and other health authority guidelines.
• Act as a backup for the RA Manager, Quality Assurance, and Pharmacovigilance, ensuring at least one qualified representative is on‑site at all times.
• Prepare for and support audits and inspections by healthcare authorities.
• Monitor evolving regulatory requirements and ensure timely renewal, maintenance, and variation of existing products.

Required profile

• Experience in regulatory affairs within the pharmaceutical, medical device, or cosmetics sectors, preferably covering Saudi Arabia and the UAE.
• Strong knowledge of SFDA regulations and the ability to interpret and apply evolving guidelines.
• Ability to work collaboratively with global and local teams and to act as a reliable backup for QA and PV functions.
• Excellent organizational skills and attention to detail to manage multiple submissions and deadlines.

Required skills

• Regulatory Affairs
• Quality Assurance
• Pharmacovigilance
• Product registration and variation processes
• Knowledge of SFDA regulatory framework