Job as Senior Scientist for M.Pharm, B.Pharm at Procter & Gamble
Procter & Gamble is the innovation leader in our industry. Virtually all the organic sales growth we’ve delivered in the past nine years has come from new brands and new or improved product innovation. We continually strengthen our innovation capability and pipeline by investing two times more, on average, than our major competitors. P&G. We interact with more than five million consumers each year in nearly 60 countries around the world. We conduct over 15,000 research studies every year. We invest more than $350 million a year in consumer understanding. This results in insights that tell us where the innovation opportunities are and how to serve and communicate with consumers.
Post : Senior Scientist – Regulatory Life Cycle Management
The Global Regulatory Life Cycle Management Team is looking for an experienced candidate who will lead new initiatives requiring changes to existing products/dossiers, roll-out of existing dossiers to white space, and day to day changes to our products keeping them on the market.
This opportunity will see you act as the regulatory representative for specific global or regional initiatives within the VMS Brand Franchise and as a strategic business partner to build bigger and better initiatives with a focus on health supplements. You will act as point contact for our local regulatory colleagues, who manage local market and authority interactions, as well as with other technical functions within MPD, Product Supply, and manufacturing sites.
• Lead and coordinate Life Cycle Management activities within the Vitamins, Minerals & Supplements franchise
• Coordinate with Local Regulatory Affairs for roll outs (expansions untapped opportunities), variations, renewals, answering health authority requests
• Maintain Global Master Dossiers and compile, review, and provide dossiers for local registration and compliance to achieve registrations for the specific product portfolio
• Provide Regulatory input for Periodic Safety Update Reports (PSURs), Periodic Quality Reports (PQRs), and Product Data Sheets (PDS).
• Advise organization of potential regulatory risks in daily activities and recommend compliant actions
• Liaise with Corporate Technical and Product Supply functions to provide the current registered details of each product.
• Ensure regulatory assessments are conducted for change controls in the Quality Tracking system
• Update the Regulatory Information Management System for all activities
• Provide strategic input into Global Product labelling and approval to enable commercial activation of product launches.
• Provide coaching to junior colleagues or new comers to the team and ensure the management of internal and external resources (consultants)
- A minimum of Scientific degree in Life-Science (pharmacy, medicine, chemistry, biology, etc.).
- Atleast 8-10 years of extensive regulatory experience preferably in consumer health across multiple regulatory classification areas (health supplements, medicines, medical devices, etc.)
- Experience developing regulatory strategies for successful launch of new products & the maintenance of existing products ideally across different countries/geographies within Asia, India, Middle East and Africa
- Proven ability to work independently in a matrix environment to build outstanding relationships with partners
- Strong initiative and follow-through with accountability for work quality
- Excellent attention to detail, communication and presentation skills
- Result oriented and self-motivating with an ability to influence others
- Demonstrated ability to balance competing priorities effectively with excellent organizational skills
- Commercial understanding of corporate and operational business issues
- Openness to change and ability to think out of the box
Experience : 5+ years
Qualification : M.Pharm, B.Pharm, M.Sc
Location : Mumbai, Maharashtra
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Regulatory Life Cycle Management
End Date : 20th December, 2019
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