Job Information
Abbott Manager / Senior Manager – Regulatory Affairs in Mumbai, India
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.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email corpjat@abbott.com