Assistant Manager - Regulatory Affairs

Role Overview: As an experienced Regulatory Affairs Specialist with a strong educational background in M. Pharmacy, you will be responsible for various key activities related to regulatory affairs in the pharmaceutical industry. Your expertise in regulatory activities such as CTD dossier preparation, query solving, and thorough knowledge of ICH guidelines will be crucial for the successful submission of dossiers to regulatory authorities. Key Responsibilities: - Prepare and submit new dossiers in compliance with regulatory requirements - Conduct gap analysis of dossiers to ensure completeness - Compile dossiers in eCTD format for submission to regulatory authorities - Coordinate the submission of dossiers in different countries - Evaluate and respond to queries from regulatory authorities - Collaborate with manufacturers to provide query responses - Ensure timely submission of query responses - Manage post-approval lifecycle of products including handling of variations - Review and compile variation packages as per country-specific guidelines - Monitor harmonization of dossiers, queries, and variations across all countries - Develop and approve artworks as per standard operating procedures - Communicate effectively with internal departments and external stakeholders - Maintain and update trackers for queries and variations on a regular basis - Attend meetings, trainings, and teleconferences with stakeholders as required Qualifications Required: - Minimum education of M. Pharmacy - Strong expertise in regulatory activities and knowledge of ICH guidelines - Experience in preparing CTD dossiers and responding to queries from regulatory authorities - Familiarity with Africa markets, especially Zazibona, South Africa, East Africa (Kenya, Tanzania, Ethiopia), and FWA - Excellent communication skills and ability to collaborate with cross-functional teams - Proven track record of meeting deadlines and ensuring compliance with regulatory requirements,