Panacea Biotec is a leading research based Health Management Company. We are engaged in research, development, manufacture & marketing of Vaccines, Bio-Pharmaceuticals and Pharmaceuticals (Rx & OTC) of international quality and Health Services. All Panacea Biotec plants are accredited by international agencies and they follow current Good Manufacturing Practices, as per WHO guidelines.
Job Title : Executive / Sr. Executive -Regulatory Affairs
Experience : 3-5 Years
Age : 26-29 Years
Location : New Delhi, Corporate Office
Education : B.Pharma, M.Pharma
- Execute the regulatory strategy for Nutraceuticals & Dietary products for India/ROW countries. Obtaining different manufacturing permissions.
- Building & maintaining a credible relationship with FSSAI/regulatory authorities.
- Providing & review of high quality documents including CMC data, regulatory compliance, electronically transmissible Data as per the agreed timelines.
- Dossier preparation & submissions for Dietary/Food supplements and Nutraceuticals in ROW & Domestic markets as per business plan.
- Responsible for sending response to FSSAI/regulatory agencies during product registration timeframes. (Preparation of clear, accessible product labels, PIL’s & artworks)
- Accountable for the timely preparation and filing of submissions, follow-up and approval of new Marketing
- Authorizations in line with agreed business plans.
- To ensure all regulatory submissions, correspondence and approvals are accurately communicated, recorded.
- Directly communicate with registration managers located in specific countries, international customers, respective regulatory authorities (MOH) regarding raised Registration status, Queries and Request of information (RFI) and to take follow-up from country specific registration managers (situated at particular country) about registration/reregistration status of products.
- Preparation of high quality Medical and Scientific communications including patient narratives, literature review, abstracts, product manuals, slide
- Sets presentations for submission to regulatory authorities.
- Development of artworks & labeling as per requirements of FSSAI/respective country.
- Preparation, Proofreading of Legal applications & Technical Documents before submission to FSSAI at Central & State level.
- Monitoring & setting timelines for license variations and renewal approvals