Manager Regulatory Affairs

JOB DESCRIPTION:

Key Accountabilities :

Propose efficient regulatory pathway for New Product Introduction
 Develop & implement regulatory strategies for new/generic product registrations in
compliance with relevant regulations and the business needs
 Provide regulatory input to CMC data, BE & CT protocol, study waiver justification etc.
related to new products filing
 Collaborate with other functions such as R&D, Quality, Supply chain, Project
Management, Medical, Clinical etc to deliver high quality dossiers, in accordance with
business priorities
 Responsible for end-to-end filing of New products(Drugs/Biologics/Biosimilars etc) to
CDSCO (Central Drugs Standard Control Organization), State FDA etc.
 Well versed with filing application of ND/SND/FDC/Import Registration/Import licence
etc on SUGAM portal
 Address queries from CDSCO/SFDA on submitted applications, provide regulatory
support for IPC/CDTL/CDL testing
 Manage submission of application dossiers with relevant regulatory authorities, monitor
the review process and take appropriate actions to obtain regulatory approvals as planned.
 Responsible for Subject expert committee (SEC) meetings including preparation of slide
deck in co-ordination with cross functional teams and SEC deliberation

Track all SEC meetings to identify and recommend new product ideas/opportunities
aligned with current business needs
 Provide Regulatory Support for timely new product launches

Minimum Education:
M. Pharm/B. Pharm
Minimum Experience Required:
8-10 years

The base pay for this position is

In specific locations, the pay range may vary from the range posted.

JOB FAMILY:

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MEDICAL SURVEILLANCE:

SIGNIFICANT WORK ACTIVITIES: