Regulatory Affairs Specialist - CMC Variations (Junior level)
vueverse.tamil nadu, tamil nadu, in2 days ago
Job descriptionStrong understanding of global CMC variation requirements. Excellent documentation, communication, and coordination skills. Attention to detail and ability to work with cross-functional teams.
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 :
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Regulatory Specialist • tamil nadu, tamil nadu, in