P&G B Pharma/M Pharma Regulatory Affairs Job – Apply Online
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Job Title: Senior Manager – Regulatory Affairs
Location: Sanand Ii, Ahmedabad
Eligbility Criteria & Experience:
- Bachelors / Masters degree in Pharmacy / medicines/allied streams
- Strong connect and experience of working with Gujarat FDA and its Ayurvedic department
- Sound Regulatory knowledge and understanding on India and Asian markets for Rx/ OTC/Ayurvedic medicines/FSSAI-regulated Health supplements and Nutraceuticals /Medical devices/Cosmetics/Advertisement regulations/E.com
- Preferably, a 2-4 years of people management experience
Develop registration strategies and lead the registration process for all OTC/non-OTC products in India (locally manufactured and/or imported), including Rx and OTC allopathic medicine, Ayurvedic medicines, cosmetics, FSSAI products.
Management of Regulatory operations in the assigned territories:
- Management of assigned regulatory projects (base and development projects).
- Devise and drive regulatory strategies to enable base business growth and deliver new innovation projects.
- Ensure regulatory compliance of registered products, promotional material and related commercial initiatives.
- Close collaboration with regulatory, medical, legal and quality functional groups.
- Provide lifecycle maintenance support for products from this site.
- Monitor, collect and interpret regulatory issues, legislations, trends and other regulatory intelligence or insights that will impact P&G business, and communicate regulatory risk assessment to the appropriate local and global P&G functions.
Regulatory due diligence and support (strategy, filings, HA meetings and Approvals from Indian authorities or concerned state FDA) for products manufactured at Ahmedabad plant or other P&G manufacturing locations in India for its registration in for export countries.
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