MSN Laboratories 70 Openings – Walk-In Drive for Regulatory Affairs on 3rd Apr’ 2021
Job
Description: (Regulatory Affairs – API Division )
Should have
minimum of 1 to 8 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 / Senior Executive Experience: 1 to 8 years in API RA field
Education: B Pharma / M Pharma / MSc
Department:
Regulatory Affairs
Job Profile:
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.
1.
Hands on experience on the
preparation of DMFs and their registration processes in the major regulatory
regions [US, Canada, Europe etc]..
2.
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.
3.
Should have hands on experience on eCTD regulatory submission
tools.
4.
Should have knowledge on the requirements to respond to the
deficiencies.
5.
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 : 03.04.2020 ( 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
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