Manager Regulatory Affairs
Manager Regulatory Affairs
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Job Description
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
N/AIn specific locations the pay range may vary from the range posted.
JOB FAMILY:
Regulatory Operations
DIVISION:
EPD Established Pharma
LOCATION:
India > Mumbai : BKC Building
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
Not specified
MEDICAL SURVEILLANCE:
Not Applicable
SIGNIFICANT WORK ACTIVITIES:
Keyboard use (greater or equal to 50% of the workday)
Required Experience:
Manager
Employment Type
Full-Time
