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

N/A

In 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)