Global Regulatory Affairs Manager (homebased)

About the role

The Global Regulatory Affairs Manager will lead regulatory activities for pharmaceutical products at the country level, ensuring compliance and successful market authorisations. This remote position supports IQVIA's global pharmaceutical clients from Dubai.

Key responsibilities

• Prepare and submit local regulatory dossiers, including renewals, variations, new applications and MAH transfers, to Health Authorities and EMA.
• Develop local product labeling (SmPC, PIL) in the required language and review artwork approvals.
• Manage multiple pharmaceutical products and act as subject‑matter expert on regulatory processes.
• Lead complex projects, author regulatory documentation, and oversee project budgets.
• Provide guidance and training to junior colleagues and review standard operating procedures.

Required profile

• Master’s degree in Life Sciences or a related discipline.
• 8‑10+ years of experience in regulatory affairs within the pharmaceutical industry.
• Fluent in English and Arabic, with strong interpersonal and communication skills.

Required skills

• In‑depth knowledge of Chemistry, Manufacturing & Controls (CMC) and regulatory guidelines.
• Experience preparing variation, renewal packages and artwork approvals.