MSN Laboratories Pvt. Ltd 50 Openings | Walk-In Drive for Regulatory Affairs on 31st Oct’ 2020
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 )
Education: B Pharma / M Pharma / M.Sc
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 : 31.10.2020 ( Saturday )
Interview Time : 9.00 AM to 1.00 PM
Venue Details :
MSN Laboratories Pvt.Ltd.,
R&D Center, Pashamylaram
Ph No : +91-8452304799
Work Location : MSN LS II (Chegunta , Chandampet).
Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field.
During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube