Walk- In Drive for Exe / Sr. Exe RA- Dept 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 Pharma / M Pharma / 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
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: 21.11.2020 (Saturday)
Interview Time: 9.00 AM to 1.00 PM
MSN Laboratories Pvt. Ltd.,
R&D Center, Pashamylaram
Ph No : +91-8452304799
Work Location: MSN LS II (Chegunta , Chandampet).