Job Description
Title: Head of Regulatory Affairs
Company Name: ACI Pharmaceuticals
Vacancy: Not specific
Job Location: Anywhere in Bangladesh
Employment Status: Full-time
Educational Requirements:
∎ Master of Pharmacy (M.Pharm), Masters degree in any discipline
Experience Requirements:
∎ At least 8 year(s)
∎ The applicants should have experience in the following business area(s):
Pharmaceuticals
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
Additional Requirements:
∎ Age 32 to 42 years
∎ Only males are allowed to apply
∎ Job Location : Dhaka
Job Source: Bdjobs.com Online Job Posting.
Application Deadline: 14 Aug 2023
Company Information:
∎ 8 Aug 2023
∎ ACI Pharmaceuticals
∎ Business : Pharmaceuticals; Agribusiness; Consumer Brands.
Category: Medical/Pharma
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