Regulatory Affairs Specialist - CMC Variations (Junior level)

Job Description CMC Variations Specialist

Experience: 24 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.