Regulatory Affairs Specialist

13 hours ago


Chennai Tamil Nadu India, Tamil Nadu vueverse. Full time

Job Description – CMC Variations Specialist

Experience: 2–4 years

Location: Chennai (Onsite)


Key Responsibilities:

  • Manage all types of CMC changes and variations (minor, moderate, major) as per country-specific regulatory requirements.
  • Collaborate and communicate effectively with client teams and stakeholders for data, clarifications, and approvals.
  • Author and compile complete variation submission packages, ensuring accuracy and compliance.
  • Review compiled packages to verify alignment with source data and regional guidelines.
  • Work across all dosage forms, including solid oral, injectables, liquids, and others.
  • Handle submissions for EU, South Africa (SA), and Australia/New Zealand (ANZ) markets.


Required Skills:

  • Strong understanding of global CMC variation requirements.
  • Excellent documentation, communication, and coordination skills.
  • Attention to detail and ability to work with cross-functional teams.


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