Assistant Manager - Regulatory Affairs (UAE and Gulf Region)

About the role

An established Indian healthcare organisation with operations across multiple markets is looking for an experienced Regulatory Affairs professional to support its UAE and wider Gulf operations. The incumbent manages regulatory registrations, approvals, renewals, variations and compliance across the UAE and GCC, working closely with regional and global teams, health authorities and internal stakeholders to support product launches, portfolio expansion and ongoing compliance.

Key responsibilities

• Manage new product registrations, renewals, variations, notifications, import permits and other regulatory submissions across UAE and GCC markets.
• Ensure compliance with regulatory requirements and maintain product registrations, marketing authorisations, licences and regulatory documentation.
• Manage product labelling, artwork, package inserts and other regulatory documentation.
• Develop regulatory strategies for new product registrations, lifecycle management, portfolio expansion and timely launches.
• Monitor changes in UAE and GCC regulatory requirements and ensure their implementation.
• Support regulatory requirements for local manufacturing, technology transfers, site additions/transfers and localisation initiatives.
• Coordinate launch readiness with Commercial, Supply Chain, Quality, Medical and other teams.
• Manage interactions with health authorities, regulatory consultants and industry bodies.
• Provide regulatory guidance for business development, licensing, launches and market expansion.

Required profile

• 10-15 years of experience in Regulatory Affairs in pharmaceutical, healthcare, medical device, cosmetics or consumer healthcare.
• Strong hands-on experience in product registrations, renewals, variations and lifecycle management across UAE and GCC.
• Experience with UAE health authorities (MOHAP, DoH, DHA).
• Exposure to regulatory inspections, GMP audits and health authority interactions.
• Experience with local manufacturing, technology transfers or site transfers in the UAE/GCC is an advantage.
• International or multinational healthcare company experience preferred.
• Fluency in English is essential; Arabic is an advantage.

Required skills

• Good understanding of GMP, GDP, quality systems and pharmacovigilance requirements.
• Strong stakeholder management, communication and project management skills.