Procter & Gamble is one of the largest FMCG (Fast Moving Consumer Goods) company in the world with strong brands like Pampers, Ariel, Always, Gillette and Oral B just to name a few.
Post : Associate Scientist Regulatory Affairs; Life Cycle Management, Personal Health Care International
1.Coordinate Regulatory Life Cycle Management activities for Cough & Cold portfolio
2. Coordinate with Local Regulatory Affairs for roll outs (expansions to white space), variations, renewals, answering health authority requests
3. Maintain Master Dossiers and compile, review, and provide dossiers for local registration and compliance to achieve registrations for the specific product portfolio
4. Provide Regulatory input for Periodic Safety Update Reports (PSURs), Periodic Quality Reports (PQRs), and Product Data Sheets (PDS).
5. Advise organization of potential regulatory risks in normal day to day activities and recommend compliant actions
6. Liaise with Corporate Technical and Product Supply functions to provide the current registered details of each product.
7. Ensure regulatory assessments are conducted for change controls in the Quality Tracking system
8. Ensure that the Regulatory Information Management system is maintained and updated for all activities under role responsibility, including review of documents
Education: A minimum of Master Scientific degree in Life-Science (pharmacy, medicine, chemistry, biology, etc.).
Languages: Proficient in English language.
- Fresh graduate or initial regulatory experience (0-2 years) preferably in consumer health and preferably across multiple regulatory classification areas (health supplements, medicines, etc.)
- Strong motivation for dossier maintenance and product change management
- Skilled in working with complex Regulatory database
- Strong initiative and follow-through with accountability for work quality
- Excellent attention to detail, good communication and presentation skills
- Results oriented and self-motivating with an ability to influence others
- Openness to change and ability to think out of the box
Qualification : M.Pharm or MSc cany
Location : Mumbai
Experience : 0-2
Industry Type : Pharma/ FMCG
End Date : 30th March, 2020
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