Regulatory Affairs Specialist
13 hours ago
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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