Regulatory Affairs Lead

1 day ago


Mumbai, Maharashtra, India Sun Pharma Advanced Research Company Ltd. Full time
Job Title: Regulatory Affairs Lead - CMC Strategy

Company Overview:

Sun Pharma Advanced Research Company Ltd. is a leading pharmaceutical company dedicated to discovering and developing innovative treatments for patients worldwide.

Job Description:

We are seeking an experienced Regulatory Affairs Lead - CMC Strategy to join our team in Mumbai, India. As a key member of our regulatory affairs department, you will be responsible for providing strategic guidance on the development and implementation of CMC (Chemistry, Manufacturing, and Controls) strategies for our drug products.

Key Responsibilities:

  • Authoring CMC sections for IND/IMPD/NDA packages and their life cycle management
  • Developing and executing overall regulatory CMC strategies for each supported program
  • Authoring CMC sections for meeting requests/briefing packages for scientific advice meetings
  • Clinical phase expertise and respective CMC requirements
  • Staying abreast of regulatory agency regulations, directives, guidelines, and policies

Requirements:

  • Educational qualification: M. Pharm/MSc
  • Good understanding of R&D processes, technology transfer, and other CMC topics for API and drug product
  • Experience in sterile dosage forms
  • Ability to manage competing priorities
  • Good communication and presentation skills

Benefits:

  • Competitive salary: ₹18,00,000 per annum
  • Ongoing training and professional development opportunities
  • A collaborative and dynamic work environment

Salary: ₹18,00,000 per annum



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