Expert Regulatory Labeling

  Pharmacy Vacancy

Job title: Expert Regulatory Labeling

Company: Merck Ltd

Job description: Your role:

  • Create and maintain global Reference Product Information/Company Core Data Sheets, based on scientific data, for mature products in co-operation with the product teams as the basis for worldwide harmonized product labeling documents
  • Lead multi-discipline labeling teams, presenting labeling proposals and reaching consensus on proposals and presentation of labeling proposals to Labeling Decision Board for internal approval of proposed labeling
  • Oversee and support implementation of Reference Product Information/Company Core Data Sheets into local/regional labeling documents
  • Provide, upon request, analysis of competitor labeling in the relevant therapeutic area
  • Update labeling for mature products, resulting in completion of internal and external approved product labeling, including Corporate, and EU CP and MRP/DCP labeling
  • Participate in labeling negotiations with regulatory agencies and review local labeling for consistency with corporate labeling
  • Monitor compliance of locally/regionally developed labeling documents for consistency with the Reference Product Information/Company Core Data Sheet and timely submission of label (safety) changes
  • Prepare labeling that supports the safe and effective use of the product that meets the company’s strategic requirements
  • Enable representatives from all major disciplines involved (e.g. Medical, GPS regulatory) to reach agreement on the best competitive labeling for the product

Who you are:

  • 9-10 years of overall work experience in Pharma environment
  • Degree in a Life Science, Medical, PharmD or related discipline (minimum MSc or equivalent degree), higher degree preferable (e.g. PhD in a scientific discipline)
  • Competent authority or Academia/R&D experience related to the role
  • Minimum 5 years of Labeling experience

Location: Electronic City, Bangalore

What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!

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Other details

Expected salary:

Location: Bangalore, Karnataka

Job date: Tue, 04 Jan 2022 08:55:15 GMT

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