Walk- In
Drive for Regulatory Affairs Dept. in API Division- R&D Center.
Openings: 70
Job Title: Executive / Senior Executive Experience: 1 to 8 years in API RA
field Education: B.Pharm / M.Pharm / M.Sc
Department: Regulatory Affairs
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: 1 to 8 years in
API RA field Education: B Pharma / M Pharma / MSc
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: 1 to 8
Years
Position: Junior Executive / Executive /Senior Executive / Junior Manager
Date of Interview:
30.01.2020 (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 & R&D Center
