Manager Senior Manager – Regulatory Affairs
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Job Location:
Monthly Salary:
Posted on:
6 days ago
Vacancies:
1 Vacancy
Job Summary
JOB DESCRIPTION:
Manager/Senior 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/State FDA 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 in alignment with current business needs
Provide Regulatory Support for timely new product launches
Minimum Education: M. Pharm/B. Pharm
Minimum Experience Required: 8-15 years
FSSAI experience desirable.
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:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Required Experience:
Senior Manager
About Company
WHO WE ARE CREATING LIFE-CHANGING TECHNOLOGY From removing the regular pain of fingersticks as people manage their diabetes to connecting patients to doctors with real-time information monitoring their hearts, from easing chronic pain and movement disorders to testing half the world’s ... View more
