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
- 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.
- 1 to 3 years