Expert Regulatory CMC

2 days ago

Bengaluru, Karnataka, India Merck Specialities Pvt. Ltd. Full time ₹ 10,00,000 - ₹ 25,00,000 per year

Your Role:

  • Support and implement CMC Regulatory Intelligence activities (NB this is a non-product specific role):
  • Databases (e.g., CMC Regulatory Country Requirements, Life Cycle Management/Investigational Medicinal Product Catalogues, Wiki-handbook) maintenance and their continuous improvement (including liaison with external data providers, as appropriate).
  • Active participation in Change Control Process meetings, Chair of Quality Regulatory Assessment Committee (QRAC) meetings and monthly updates sessions, author/co-author of Position Papers and responses to Reg CMC queries, SME for guidelines revision, etc.).
  • Ensure alignment between CMC Regulatory Intelligence and GRA CMC & Device teams (e.g., by improving interoperability, agility, engagement and cohesion).
  • Deliver, from a non-product specific perspective, on small molecules, large molecules, medical devices (i.e., drug-device combinations) with regards to marketed post-approval activities as per CMC Regulatory Intelligence Road maps.
  • Participation in Trade Association calls in listening & learning/observer mode by leveraging the discussion and lessons learnt onto CMC Regulatory Intelligence databases.
  • Provide support on digitalization projects.
  • Effective utilization of Veeva system for all the CMC regulatory activities.

Who You are:

Education

  • 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) or education in Regulatory Affairs.
  • 10 years of overall work experience (e.g. generated in Pharma environment, Competent authority, Academia, R&D, Consultancy) related and applicable to this CMC Regulatory Intelligence role. Minimum 5 years of Global CMC regulatory experience.

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