Manager / Senior Manager – Regulatory Affairs

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/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:

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)