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.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.
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:
Exp: 1-3 years
Location: New Delhi, Delhi
Qualification: B.Pharm, M.Pharm
Functional Area: Regulatory Affairs
Send your application to singhjyoti@panaceabiotec.com
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