Pharma Job @ Panacea Biotec | Apply Online for Executive – Regulatory Affairs Post


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

Desired Profile:

  • 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

Click here to Apply Online


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