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:
- Compilation and review of dossiers in as per eCTD/CTD/ACTD/Country Specific formats for product Registration.
- Maintain dossier submission, filing, approval & deficiency
- Compilation and submission of queries and variations.
- Review of documents, artworks
- Review of change controls
- Gap analysis for new product filing
- Maintaining product Life cycle
- Knowledge w.r.t. Injectable, OSDs.
- Knowledge of Country specific requirements for Emerging Markets – regions: Latam and Brazil
- Looking forward for a candidate having team handling experience.
Link to original Notification to apply: Apply here
Keywords: Assistant Manager, Regulatory Affairs, Emcure Pharmaceuticals, Pune, Maharashtra, India, Executive, LATAM, Brazil, DGM RA, Team, B.Pharm, M.Pharm, eCTD, CTD, ACTD, Country Specific, product Registration, dossier submission, filing, approval, deficiency, queries, variations, documents, artworks, change controls, gap analysis, new product filing, product Life cycle, Injectable, OSDs, Country specific requirements, Emerging Markets. Emcure Pharmaceuticals Regulatory Affairs Job – Apply Online. Subscribe to Rasayanika for the latest chemistry and Pharma job openings, follow us on Facebook and Telegram and subscribe to our youtube channel for the latest updates on chemistry and Pharma jobs and much more.
