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
Apply/Forward your Resume, singhjyoti@panaceabiotec.com
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