Assistant Manager – Regulatory Affairs

Manage and support regulatory submissions and approvals for international markets, particularly French-speaking regions. Prepare, review, and evaluate CTD dossiers for regulatory submissions. Coordinate international submissions and regulatory activities with Ministries of Health (MoH) and other regulatory authorities. Handle regulatory procedures including EU DCP, MRP, and National Procedures. Manage regulatory activities for Morocco and/or Francophone African markets. Ensure regulatory submissions comply with applicable ICH guidelines and EU/EMA regulations. Coordinate with internal teams and regulatory authorities to address queries, deficiencies, and submission requirements. Monitor regulatory changes and assess their impact on ongoing and future submissions. Support the preparation and maintenance of regulatory documentation throughout the product lifecycle.

M.Pharm or equivalent qualification in Pharmacy/Pharmaceutical Sciences. 5–10 years of relevant experience in Regulatory Affairs, preferably in international markets. Proven experience in CTD dossier evaluation and international submissions to Ministries of Health (MoH). Hands-on experience with EU regulatory procedures, including DCP, MRP, and National Procedures. Experience dealing with Moroccan and/or Francophone African regulatory agencies. Strong knowledge of ICH guidelines and EU/EMA regulatory requirements. Good understanding of regulatory procedures applicable to French-speaking markets. French language proficiency is required/preferred for managing French-speaking markets. Strong analytical, documentation, coordination, and communication skills.