P&G Pharma Regulatory Affairs Job - Apply Online

P&G Pharma Regulatory Affairs Job – Apply Online

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Job Title: SENIOR MANAGER – REGULATORY AFFAIRS

Job locations: Sānand, Gujarat, India

Job Type: Full time

Job categories: Research And Development

Req No: R000066548

Eligbility Criteria: 

  • 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

Advice I Training/Compliance/other scope of work:

  • Variation and Renewal of all licenses on time
  • Change Control Management, Artwork Review, Specifications, Dossier readiness
  • 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) .

Regulatory Strategy:

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.

Apply Online

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