Walk- In Drive for
Regulatory Affairs Dept.in API Division- R&D Center.
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:
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 :
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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