Job Description
Our client a Multinational Pharmaceutical Company is looking for an experienced Regulatory Affairs Manager to oversee and manage regulatory activities across their strategic partnerships in the Middle East, Africa, and Asia.
Client Details
Our client a Multinational Pharmaceutical Company is looking for an experienced Regulatory Affairs Manager to oversee and manage regulatory activities across their strategic partnerships in the Middle East, Africa, and Asia.
Description
This role is essential to supporting the growth of the medicinal product portfolio while leading a talented team of regulatory professionals.
Key Responsibilities:
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.Act as the primary point of contact with regulatory authorities, ensuring clear and effective communication for all assigned projects.Collaborate closely with distribution partners to meet regulatory needs, plan variations, and update marketing authorization dossiers.Stay up-to-date with international regulatory guidelines, promoting compliance and best practices across the team.Drive process improvements, manage regulatory tools and platforms, and maintain regulatory databases.Prepare monthly status reports, project metrics, and workload forecasts to ensure transparency and effective tracking of timelines and budgets.
Profile
The ideal candidate for the role will have:
A Pharmacy degree or equivalent, with a Master's in Regulatory Affairs.7-10 years of experience in Regulatory Affairs, with a proven track record of team management.The candidate needs to be based in UAE with strong experience working in the country Experience in a multinational environment, with a focus on regulatory strategy across the Middle East and Asian markets.In-depth knowledge of regulatory documentation, time lines, and budgeting.Excellent communication and leadership skills, with the ability to thrive in a multicultural environment.Fluency in English is required; French and Arabic language skills are a plus.
Job Offer
The selected candidate will be offered a competitive salary plus medical insurance, flight tickets and a bonus. The benefits are for self and family. The role is ideal for an experienced Regulatory Affairs Manager to expand the scope of the geographies they cover and further grow in their career.
