MSN Laboratories is amongst the world’s fastest-growing Pharmaceutical Company having 9 API Plants. MSN crated Benchmarks in Developing Complex drugs, Economically feasible, Making it No -1 in active DMF’s in the world.
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MSN is committed to Nurturing the Exceptionally talented peoples, Professionally.
Position: Executive/Sr Executive Regulatory Affairs
Location: Hyderabad
Division: API
Job Description:
1. Collecting and reviewing the documents received from various departments R&D, AR&D, QA, QC, and Production, etc at each and every stage of manufacturing of drug substances to minimize the errors at the time of submission to regulatory agencies.
2. Hands-on experience on the preparation of DMFs and their registration processes in the major regulatory regions [US, Canada, Europe, etc
3. Hands-on experience on preparation of drug master files, Applicants Parts, Tech Pack, life cycle management [updates and amendments], and drafting of response to deficiencies and customer DMF review comments for all global regions.
4. Should have hands-on experience on eCTD regulatory submission tools.
5. Should have knowledge of the requirements to respond to the deficiencies.
6. Participation in the cross-functional team meetings and providing regulatory inputs to the Product Development Teams.
Qualification: B.Pharma, M.Pharma/M.Sc
Experience: 1-7 Years
Salary: Negotiable
Contact Details:
simhachalam.piniminti@msnlabs.com, hr@msnlabs.com
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