REGULATORY AFFAIRS EXECUTIVE

Job description

Key Responsibilities:

 DMF Preparation o Ability to prepare dummy Open Part and Closed Part of a Drug Master File (DMF). o Collect and compile required documents/data from the manufacturing site for DMF creation.

 Dossier Management o Review, prepare, and compile various sections of regulatory dossiers as per international regulatory requirements.

 Regulatory Query Handling o Independently handle and resolve queries raised by regulatory authorities, including:

 Ministry queries for Open and Closed Parts of DMF.

 TMDA (Tanzania Medicines and Medical Devices Authority) queries.

 Analytical & Technical Documentation o Prepare Analytical Method Validation (AMV) reports for both drug substances and finished products. o Provide guidance on impurity characterization strategies without actual laboratory testing, using regulatory-acceptable approaches (e.g., literature data, Q3A/Q3B guidelines, read-across, in-silico tools).