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Opportunity for Executive/Sr. Executive –Regulatory Affairs in Panacea Biotec

 

Clinical courses

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/Sr. Executive –Regulatory Affairs

Job Description
- Regulatory & Manufacturing inputs, Documents review, Dossier filing in ROW countries, Handling of regulatory issues, Query responses, Co-ordination with distributor/Agent
- To give Regulatory & Manufacturing inputs to R&D, CRD & at Mfg. site during development & Manufacturing of Exhibit batches.
- Collecting, & Collating of data from functional department & filing of dossier.
- Handling of issues like Changes, complaints, regulatory compliances, notifications, Post registration activities & Variation filing
- Co-ordination with QA for plant inspection by NRA of respective Country.
- Review of dossier & query responses. Arrangements of Samples & columns
- Documents review-CMC data, Process validation, AMV, Specifications, STP, DMF, Clinical & non clinical data, Stability reports & SMF according to country specific requirements. Co-ordination & arrangement of Tender documents from PBL Locations and State Drugs Authorities.
- Review of MOH approved documents- RC, NTD, Artworks, PI to inline the commercial supplies
- Product Life cycle Management- PIF, IPR clearance, Dossier, Queries, Registration status, Sharing of RPI, Registration renewal, Tender documents, Collection of registration invoices.
- Handling of ADR's, Submission of PSUR's, Arrangements of Licenses, RLD & upkeep of the records.

Additional Information:
Experience: 4-6 years
Age: 24-28 Years
Location: New Delhi
Education: M.Pharm

Industry Type: Pharma/Biotech/Vaccines
Compensation: As per Industry Norm
Functional Area: DRA
Last Date: 25th June, 2015


Apply/Forward your Resume, careers@panaceabiotec.com

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