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Executive-Regulatory Affairs Post for B.Pharm & M.Pharm @ Panacea Biotec

Panacea Biotec

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.

We offer stimulating work environment & a career that spells growth. In tune with our plans, we require young, aggressive, dynamic, high performing and result oriented professional.

Job Title   Executive-Regulatory Affairs (Pharma)

Age Limit:  24 to 26 Years

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.

Qualifications

  • 1 to 3 years
  • B.Pharm/M.Pharm

Apply Online

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