Walk- In Drive for Regulatory Affairs Dept.in API - Division- R&D
Center.
Regulatory Affairs API RA Dept in API Division,
Job Description: (Regulatory Affairs - API Division)
Should have minimum of 2 to 8 years of experience in API Regulatory Affairs
Job Title: Executive / Senior Executive Experience: 2 to 8 years in API RA
field
Education: B.Pharm / M.Pharm / M.Sc
Department: Regulatory Affairs - API
Job Title: Executive / Senior Executive Experience: 2 to 8 years in API RA
field Education: M Sc
Department: Regulatory Affairs -API
Job Profile:
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 on the requirements to respond to the deficiencies.
6. Participation in the cross functional team meetings and providing regulatory
inputs to the Product Development Teams.
Drug Regulatory Affairs API RA Dept.
Experience:
2 to 7 Years
Position: Junior Executive / Executive /Senior Executive
Date of Interview:
17.10.2020 (Saturday)
Interview Time:
9.00 AM to 1.00 PM
Venue Details:
MSN Laboratories Pvt.Ltd.,
R&D Center, Pashamylaram
Ph No : +91-8452304799
040-30438786
Work Location: MSN LS II (Chegunta , Chandampet).
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