MSN Group is one of the fastest growing manufacturers of Active Pharmaceutical Ingredients (APIs) and Finished dosages in India.Established in the year 2003, MSN Group comprises of eight API manufacturing plants ( including one for Oncology), two finished dosage facility ( one more for Oncology being built) and a dedicated R&D Center and is growing 30-40% every year. Our plants are ISO 9001-2000 certified,WHO: GMP, EU:GMP and USFDA approved. Our manufacturing units are designed to confirm to the principles of Quality, Safety and sound Environment.
Eligibility and other details :Â Â
- Post Name:Regulatory Affairs Manager
- Qualification:B.Pharma,M.Pharma,B.Sc,MS/M.Sc(Science)-Chemistry with 02-07 Years of Experience
- Location: Hyderabad
- Salary:Not Disclosed by Recruiter
- No Vacancies: 01
- Time & Venue:1st February , 9 AM onwards
MSN Laboratories Pvt.Ltd., R&D Center,plot no.12, Phase-IV,Sy.no.119, IDA
Pashamylaram,ptancherru,sangareddy,502307. Ph No : +91-8452304702/4789
- Selection Process : Based on Resume Received,will shortlist
Job description:
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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.
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Hands on experience on the preparation of DMFs and their registration processes in the major regulatory regions [US, Canada, Europe etc]..
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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.
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Should have hands on experience on eCTD regulatory submission tools.
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Should have knowledge on the requirements to respond to the deficiencies.
Pramod V. Gaikwad
Dear sir/madam
My self pramod Gaikwad.
I have completed D.E.E & B.E in electrical engineering and I have 10 years experience in electrical engineering.
Job location:- Aurangabad,Maharashtra
Thanks and Regards
Gaikwad P.V.