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Vacancy for M.Pharm, B.Pharm in Regulatory affairs at Panacea Biotec

Panacea Biotec is a leading research based Health Management Company, with an annual turnover of approx. Rs. 830 Crores. 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.

Post: Executive-Regulatory Affairs (Pharma)

Job Description

  • Dossier compilation & submissions for pharmaceutical product in Asian/ African Countries as per plan.
  • Review of query and to ensure timely response to queries from Regulatory Agency.
  • Filling of change variations and maintaining product life cycle changes post registration.
  • Review of QMS documentation and evaluating its impact on product dossiers.
  • Co-ordination with Plant QA & Regulatory Agency for GMP application.
  • Documents review viz. Process validation, Specifications, STP, DMF, Stability reports,  SMF and Clinical & Non-Clinical Data according to Country Specific requirements.
  • Co-ordination with cross function team for Data collection for Dossier Filing.

Additional Information
Experience: 1-3 Years
Age: 24 to 26 Years
Location: Delhi
Education: B.Pharm, M.Pharm

Industry Type: Pharmaceutical/ Biotechnology
Compensation: Best in the industry
Functional Area: Regulatory Affairs
Last Date: 20th June, 2018

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