GlaxoSmith Assistant
Manager – Regulatory Affairs Post graduate in Pharmacy or Science
Job Purpose:
Preparation
of registration dossier for securing licenses for new product introduction as
well as life cycle management of imported Pharma and Biological (Vaccines and
r-DNA derived) products for domestic (India) market.
Responsibilities
Assist the
Regulatory Affairs Manager in fulfilling regulatory responsibilities for
activities related to registration of new drugs and lifecycle management of
Biologicals [Vaccines and Biopharm] and Pharmaceuticals for domestic market.
Compile
Regulatory Dossiers for offline as well as online submission (SUGAM) of:
New Drug
Registration (NDA), Clinical Trial Applications (IND), Registration
Certificates and Import Licenses
Renewals of
Registration Certificates/Import Licenses
Manufacturing
Variations
Clinical
Trial Maintenance applications
Prescribing
Information Updates
Post approval
commitments
Review and
approval of artworks for assigned products.
Liaise with
Global Regulatory Affairs (GRA) team for Regulatory requirements of various
submission activities
Ensure
compliance to GSK processes as well as requirements of Drugs and Cosmetics Acts
and Rules for the assigned products & projects
Track and
maintain the NPI activities and product lifecycle on local XL database for the
projects assigned
Track and
maintain submission and approval status & follow-ups on GSK Global RA
Systems.
Education:
Post graduate in Pharmacy or Science
Job-Related
Experience :
Approx. 4-5
years of experience in handling regulatory dossier preparation and filing with
CDSCO office for imported assets preferably in the biological space
Other
Job-Related Skills/Background:
Good
knowledge of Drugs and Cosmetic Acts and Rules with respect to new drug
permission, import and registration and life cycle management
Proficiency
in spoken and written English
Project
management skills
Hands on
experience of handling SUGAM portal
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