Manager / Senior Manager – Regulatory Affairs
Abbott Laboratories Mumbai
Manager/Senior Manager Regulatory Affairs
business priorities
Job Description
Key Accountabilities:
Propose efficient regulatory pathway for New Product Introduction- Develop & implement regulatory strategies for new/generic product registrations in
- Provide regulatory input to CMC data, BE & CT protocol, study waiver justification etc.
- Collaborate with other functions such as R&D, Quality, Supply chain, Project
business priorities
- Responsible for end-to-end filing of New products(Drugs/Biologics/Biosimilars etc) to
- Well versed with filing application of ND/SND/FDC/Import Registration/Import licence
- Address queries from CDSCO/State FDA on submitted applications, provide regulatory
- Manage submission of application dossiers with relevant regulatory authorities, monitor
- Responsible for Subject expert committee (SEC) meetings including preparation of slide
- Provide Regulatory Support for timely new product launches
Minimum Experience Required: 8-15 years
FSSAI experience desirable.
Ernst & YoungMumbai
provide you with motivating and fulfilling experiences throughout your career to help you on the path to becoming your best professional self.
The opportunity : Senior Manager-National-TAX-TAX - GCR - ACR - Mumbai
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AccentureMumbai
Skill required: Marketing Operations - Operations Management
Designation: Portfolio Delivery Lead Senior Manager
Qualifications:Any Graduation
Years of Experience:16 to 25 years
About Accenture
Accenture is a global professional services company...
Michael PageMumbai
About Our Client
Leading asset management company based out of Mumbai.
Job Description
• Formulation and review of various risk & investment related policies such as Investment risk policy, Investment policy, Valuation policy etc.
• Performance...