15.0 - 20.0 years

22 - 25 Lacs

Coimbatore

Work from Office

Should have working knowledge, experience in field of Agriculture inputs and insight into the following aspects: a) Research experience in the discovery of potential Actives from Plant/Microbial/Mineral etc., in the development of most essential Agri-inputs. b) Designing of feasible techno-economical projects: Submission of independent & collaborative projects to DBT/DST etc., towards development of products with market potential, complying with the requirements of national/international standards.

Posted 9 hours ago

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Assistant Manager Regulatory Affairs- International Bharat Serums and Vaccines

6 - 10 years

8 - 13 Lacs

Navi Mumbai

Work from Office

Role & responsibilities 1. Preparation and reviewing of CTD and ACTD dossier. 2. Co-ordination with Plant and R&D to collect inputs required for Regulatory Submission. 3. Co-ordination with plant for Regulatory compliances. 4. Timely achievement of monthly plan & timely query response. 5. Gap Analysis/Updation of Master data. 6. Review of Change Controls, Stability Protocol, Clinical Trial Protocols & Artworks. 7. Get feedback from all the countries for respective variation, and their timely submission. 8. renewals. 9. Master data Updating. 10. Follow ups with plant for documentation regularly and review meeting. Tracking and reviewing of document requirements of upcoming new filing in ROW and Emerging markets Preferred candidate profile Key Skills: eCTD, CTD, Validation, ICH requirements, USFDA Filings, EMA Filings, WHO Prequalification, MCC South Africa for Biological and Biotech products. Must have exposure to in-licensed dossier filing and out licensing Candidates with 6+ years of relevant experience. Candidate must have experience on Bio pharma products

Posted 1 month ago

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