Head of Regulatory Affairs

Job Responsibilities

• Ensuring compliance with regulations set by the local regulatory authority (DGDA).
• Preparing, compiling & Reviewing Registration documents.
• Communicating with authorities & updating the status of product registration, renewal and price approval.
• Reviewing the common technical documents (CTD) provided by QA, QC, and R&D departments for registration.
• Handling queries raised by Regulatory authorities during the evaluation of technical data.
• Coordinating concerned (PD, QA, QC, Production, Marketing, SCM) departments in the process of pre-registration, registration, amendment, sample for DTL testing, approval of price and renewal of registration of all products.
• Interacting with various administrative, legal & factory departments to collect documents required for regulatory compilation on time.
• Ensuring manufactured products are appropriately licensed, produced and marketed with the regulations of the Directorate General of Drug Administration (DGDA), Bangladesh.
• Undertaking and managing regulatory inspection, escorting government inspectors during inspections and providing post-inspection follow-up information as requested.
• Interacting with various administrative, legal & factory departments to collect documents required for regulatory compilation on time.
• Recommending changes to company procedures in response to changes in regulations or standards.
• Coordinate recall or market withdrawal activities as necessary.
• Reviewing and following up on adverse drug reaction reports submitted to DGDA and attend meetings of DGDA regarding pharmacovigilance as a core member of the PV team of ACI.
• Updating FDA, WHO warnings and precautions on insert
• Liaison with DGDA in terms of all PV-related activity with DGDA.
• Play a role in PV Salesforce training.
• Liaising with regulatory authorities.
• Conducting activity of Project approval from DGDA.
• Handling and coordinating all activities related to the narcotics and explosives department.
• Handling and coordinating the Registration of special products (Biosmilar) and Medical Devices from DGDA