Exciting Job Opening for Assistant Manager – Regulatory Affairs in Pune!

ign: center;">Emcure Pharmaceuticals Regulatory Affairs Job – Apply Online

Assistant Manager – Regulatory Affairs

Emcure Pharmaceuticals Limited · Pune, Maharashtra, India

Executive/Assistant Manager – Regulatory Affairs

Job Location: Pune

Experience: 6-9 Years

Qualification: B.Pharm/M.Pharm

Markets: LATAM, Brazil

Reporting: DGM RA

Team: 2

Job description:

1. Compilation and review of dossiers in as per eCTD/CTD/ACTD/Country Specific formats for product Registration.
2. Maintain dossier submission, filing, approval & deficiency
3. Compilation and submission of queries and variations.
4. Review of documents, artworks
5. Review of change controls
6. Gap analysis for new product filing
7. Maintaining product Life cycle
8. Knowledge w.r.t. Injectable, OSDs.
9. Knowledge of Country specific requirements for Emerging Markets – regions: Latam and Brazil
10. Looking forward for a candidate having team handling experience.

Link to original Notification to apply: Apply here

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