Walk-In Drive for API -Regulatory Affairs -Department 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 15 years of experience in API Regulatory Affairs
Job Title: Executive / Senior Executive Experience: 1 to 8 years in API RA field
Education: B Pharma / M Pharma / MSc
Department: Regulatory Affairs
Job Title: Executive – Manager Experience: 2 to 15 years in API RA field
Education: M.Sc / B.Pharm / M.Pharm
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.
Job Title: Junior Manager / Assistant Manager Experience: 6 to 10 years in API RA field
Education: M.Sc
Department: Regulatory Affairs
Job Profile:
1. Good scientific conceptual background to the level to evaluate the processes and procedures in the area of Quality, R&D, AR&D and Production.
2. Manageable communication in English [should be able to manage regulatory and scientific discussions in the internal and external meetings and one to one interactions within the organization and with customers]
3. Manageable knowledge on the regulatory and quality guidelines from various regulatory agencies ICH, FDA, EMA, Health Canada, ANVISA, PMDA, MFDS, CFDA etc.
4. Thorough knowledge and hands on experience on the DMF registration and marketing authorization application systems in the major regulatory regions [US, Canada, Europe etc]..
5. Hands on experience on preparation of drug master files, life cycle management and drafting of response to deficiencies and customer DMF review comments for all global regions.
6. Should have knowledge on product developmental and the quality systems to ensure the regulatory compliance.
7. Should have hands on experience on eCTD regulatory submission tools.
8. Conducting meetings for the deficiencies received from various regulatory agencies and should have knowledge on the requirements to respond to the deficiencies. Ensuring that the accurate and adequate responses are sent to the authorities within the timelines defined by agencies.
9. Thorough review and ensuring that the regulatory submissions are adequate and error free with minimum open issues and closing of open issues before filing or before the receipt of deficiencies.
10. Participation in the cross functional team meetings and providing regulatory inputs to the Product Development Teams.
11. 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.
12. Review and assessment of change controls and providing guidance to the team on proposed changes.
13. Ensuring that the regulatory databases are properly maintained and updated on time to time for each regulatory activity.
Drug Regulatory Affairs API RA Dept.
Exp : 2 to 15 Years
Position: Executive – Manager
Work Location : MSN LS II & R&D Center
Date of Interview : 08-10-2021 ( Friday )
Interview Time : 9.00 AM to 1.00 PM
Venue Details :
MSN Laboratories Pvt. Ltd.,
R&D Center, Pashamylaram
Ph No : +91-8452304799/4899
040-30438786
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