Sr. Executive, Regulatory Affairs
Job Description
Title: Sr. Executive, Regulatory Affairs
Company Name: Synovia Pharma PLC, a subsidiary of Beximco Pharmaceuticals Limited
Vacancy: Not specific
Job Location: Dhaka
Employment Status: Full-time
Educational Requirements:
∎ B.Pharm or M.Pharm from a well reputed institution
Experience Requirements:
∎ At least 4 year(s)
Job Responsibilities:
∎ Prepare and collect new product registration and renewal documents for both local and imported products and submit to Directorate General of Drug Administration (DGDA)
∎ Maintain liaison with different departments of the organization and share updates about status of inclusion materials for new products
∎ Prepare CTD (Common Technical Documents) and ACTD (ASEAN Common Technical Documents) and dossiers for export markets, and review and prepare different technical documents associated with CTD/ACTD preparation
∎ Provide updated regulatory information to concerns dept. and follow up for implementation
∎ Respond to different queries raised by different regulatory authorities associated with dossier evaluation or facility inspection by local health authority (HA) or HA from abroad (for export)
∎ Prepare Recipes, Annexures etc. and collect samples for Drug Testing Laboratories (DTL) as per requirement
∎ Check the newly developed artworks of different packaging materials (PM) with annexure for local and export markets
∎ Review promotional materials in Regulatory point of views, ensure updated product API and label claims as per DGDA approved leaflet and ensure timely submission of promo-materials
∎ Ensure approval of promotional material by DGDA according to the need of Marketing
∎ Prepare price related documents for MRP/IP, submit to DGDA and get them approved
∎ Prepare and organize manufacturing & GMP license related documents for DGDA
∎ Work closely as a team with Marketing, Medical, New Product Dept. Production, QC, Supply Chain, Finance and HR Dept.
Additional Requirements:
∎ At least 4 years' experience of working in regulatory function in a leading pharmaceutical company of Bangladesh with special focus to DGDA related activities
∎ Habituated to perform within given timeline
∎ Strong desire for learning new things and new ways of work
∎ Commendable interpersonal skill and long term relationship building capability with stake holders
∎ Good communication skill, oral and writing, both in English and Bangla
∎ Good ability in using MS Office - Word, Excel, PowerPoint, Outklook etc.
∎ Willingness to work under pressure beyond working hours to meet deadlines
∎ Very good persuasive ability and negotiation skill
∎ 'Can Do' attitude
Job Source: Bdjobs.com Online Job Posting.
Application Deadline: 25 Dec 2022
Company Information:
∎ 10 Dec 2022
∎ Synovia Pharma PLC, a subsidiary of Beximco Pharmaceuticals Limited
∎ Business : Sanofi Bangladesh Limited is renamed Synovia Pharma PLC. on April 01, 2022.
Sanofi Bangladesh Limited was part of global biopharmaceutical company Sanofi S.A. before the majority stake (54.6%) acquisition by Beximco Pharmaceuticals Limited on October 1, 2021. Sanofi Bangladesh started its operation in Bangladesh as part of the British chemical company May & Baker in 1958. Following a series of mergers and acquisitions (Fisons of United Kingdom, Rhône-Poulenc of France and Hoechst Marion Roussel of Germany) it became known as Sanofi-Aventis in 2004, before being renamed in 2013 as Sanofi Bangladesh Limited.
Synovia Pharma has inherited Sanofi Bangladesh`s state-of-the-art manufacturing facilities, including a PIC/s certifiable manufacturing facility for cephalosporin antibiotics, are spread over 25 acres of land, located at Tongi, Gazipur Bangladesh.
Synovia Pharma is continuing to manufacture and market Sanofi products in Bangladesh, just as before, and in addition the new company will provide an expanded portfolio of products to address the unmet medical needs of the patients. Synovia Pharma remains committed to value creation via synergy of strengths of the two ethical entities and will continue to bring hope, health and happiness in the lives of people we touch.
Category: Medical/Pharma
