Regulatory Affairs Manager

This role is essential to supporting the growth of the medicinal product portfolio while leading a talented team of regulatory professionals.

Key Responsibilities:

1. Manage and lead a team of Regulatory Affairs officers, ensuring timely and efficient regulatory submissions, including Marketing Authorization Transfers, CMC variations, labelling updates, and renewals.
2. Act as the primary point of contact with regulatory authorities, ensuring clear and effective communication for all assigned projects.
3. Collaborate closely with distribution partners to meet regulatory needs, plan variations, and update marketing authorization dossiers.
4. Stay up-to-date with international regulatory guidelines, promoting compliance and best practices across the team.
5. Drive process improvements, manage regulatory tools and platforms, and maintain regulatory databases.
6. Prepare monthly status reports, project metrics, and workload forecasts to ensure transparency and effective tracking of timelines and budgets.

The Successful Applicant

The ideal candidate for the role will have:

1. A Pharmacy degree or equivalent, with a Master's in Regulatory Affairs.
2. 7-10 years of experience in Regulatory Affairs, with a proven track record of team management.
3. The candidate needs to be based in UAE with strong experience working in the country.
4. Experience in a multinational environment, with a focus on regulatory strategy across the Middle East and Asian markets.
5. In-depth knowledge of regulatory documentation, timelines, and budgeting.
6. Excellent communication and leadership skills, with the ability to thrive in a multicultural environment.
7. Fluency in English is required; French and Arabic language skills are a plus.