Regulatory Affairs Specialist - CMC Variations

Description:

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