Regulatory Affairs Specialist - CMC Variations

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 :

(ref : iimjobs.com)