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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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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