Assistant Manager-Regulatory Affairs (UAE and Gulf region) (PSS08138)

About the Company

An established Indian healthcare organisation with business operations across multiple markets is looking to appoint an experienced Regulatory Affairs professional to support its UAE and wider Gulf operations.

Position Overview

The incumbent will be responsible for managing regulatory registrations, approvals, renewals, variations and compliance activities across the UAE and GCC markets. The role will involve close coordination with regional and global teams, health authorities and internal stakeholders to support product launches, portfolio expansion and ongoing regulatory compliance.

Key Responsibilities

• Manage new product registrations, renewals, variations, notifications, import permits and other regulatory submissions across UAE and GCC markets.
• Ensure compliance with applicable 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 to support new product registrations, lifecycle management, portfolio expansion and timely product launches.
• Monitor changes in UAE and GCC regulatory requirements and ensure their implementation across the organisation.
• Support regulatory requirements relating to local manufacturing, technology transfers, site additions/transfers and localisation initiatives.
• Coordinate launch readiness activities with Commercial, Supply Chain, Quality, Medical and other cross-functional teams.
• Manage interactions with relevant health authorities, regulatory consultants and industry bodies.
• Provide regulatory guidance for business development, licensing, product launches and market expansion initiatives.

Required Experience & Qualifications

• 10–15 years of experience in Regulatory Affairs within the pharmaceutical, healthcare, medical device, cosmetics or consumer healthcare industry.
• Strong hands-on experience in product registrations, renewals, variations and lifecycle management across UAE and GCC markets.
• Experience dealing with UAE health authorities, including MOHAP, DoH and DHA.
• Exposure to regulatory inspections, GMP audits and health authority interactions.
• Experience supporting local manufacturing, technology transfers, site transfers or localisation initiatives in the UAE/GCC region will be an advantage.
• Good understanding of GMP, GDP, Quality Systems and Pharmacovigilance requirements.
• Strong stakeholder management, communication and project management skills.
• International or multinational healthcare company experience would be preferred.
• Fluency in English is essential; Arabic language skills would be an advantage.

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