P&G was founded over 180 years ago as a simple soap and candle company. Today, we're the world’s largest consumer goods company and home to iconic, trusted brands that make life a little bit easier in small but meaningful ways. We've spanned three centuries thanks to three simple ideas: leadership, innovation and citizenship. The insight, innovation and passion of hardworking teams has helped us grow into a global company that is governed responsibly and ethically, that is open and transparent, and that supports good causes and protects the environment. This is a place where you can be proud to work and do something that matters.
Post : Senior Manager - Regulatory Affairs
Job Description
Continuous mentorship – you will collaborate with passionate peers and receive both formal training as well as day-to-day mentoring from your manager dynamic and supportive work environment– employees are at the centre, we value every individual and support initiatives, promoting agility and work/life balance.
Regulatory Strategy :
• Develop and implement regulatory strategies that enable the delivery of product innovations and growth of base business to meet overall business objectives
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.
• Monitor, collect and interpret regulatory issues, legislations, trends and other regulatory intelligence or insights that will impact PGT business, and communicate regulatory risk assessment to the appropriate local and global PGT functions.
External Affairs :
• Interface with relevant government agencies, industry associations and key opinion leaders to assess the impact and implementation of required compliance initiatives to meet all regulations, laws and industry policies that affect the ingredients, packaging, marketing, advertising, labelling and production of our products.
• Interface and represent company interests with relevant government agencies, industry associations and/or other organizations for the purpose of negotiating legislation, regulations and/or guidelines that do not impose excessive or unfair burdens on our industry or products.
Collaboration with MFTs / Regulatory Leadership
• Day to day collaboration with Multifunction teams, LTs for projects and deliverables
Advice I Training/Compliance/other scope of work :
• Provide training / coaching to RA teams on functional matters
• Provide advice and training on regulatory compliance to the local business.
• Ensure compliance requirements are met.
• Ensure full compliance of all marketed products and marketing/sales activities with national regulatory requirements including but not limited to advertising, packaging and communications, and import/export procedures.
• Management of Regulatory and compliance activities for assigned export markets (Sri Lanka, Nepal, and other assigned territories) .
• Develop registration strategies and lead the registration process for all OTC/non-OTC products in India (locally manufactured and/or imported), including OTC allopathic medicine, Ayurvedic medicines, cosmetics, vitamins, health food, and supplements.
Candidate Profile
1. Sound Regulatory knowledge and understanding on India and Asian markets for Rx/ OTC/Food supplements/Medical devices/Cosmetics/Advertisement regulations/E.com
2. Overall 10-12 years of experience and preferably a minimum of 5-6 years of people management experience
3. Bachelors / Masters degree in Pharmacy / medicines / allied Science streams
Additional Information
Experience : 10-12 years
Qualification : M.Pharm, M.Sc
Location : Mumbai
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : Regulatory Affairs
End Date : 25th September, 2022
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