If you’re looking to grow your career in Regulatory Affairs with a focus on CMC Variations, this is a great opportunity to join a fast-growing organization in Chennai. The role is ideal for professionals with 2–4 years of hands-on experience in global CMC changes, variation submission management, and regulatory documentation across multiple markets.
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About the Role
The Regulatory Affairs Specialist – CMC Variations will be responsible for end-to-end management of CMC change control, authoring and reviewing variation packages, and ensuring compliance across EU, South Africa (SA), and ANZ regulatory markets.
This role is fully on-site in Chennai, requiring strong coordination, communication, and documentation expertise.
Key Responsibilities
- Manage all types of CMC changes and variations (minor, moderate, major) as per region-specific regulatory requirements.
- Collaborate with clients and internal stakeholders for clarifications, approvals, and data collection.
- Author and compile accurate, compliant variation submission packages.
- Review compiled dossiers to ensure alignment with source data and guidelines.
- Handle submissions across solid orals, injectables, liquids, and multiple dosage forms.
- Execute variation submissions for EU, SA, and ANZ markets.
Required Qualifications
- 2–4 years of experience in CMC variations and regulatory affairs.
- Strong knowledge of global CMC variation guidelines.
- Excellent documentation, coordination, and communication skills.
- Ability to work across cross-functional teams with attention to detail.
Benefits
- Opportunity to work in a global regulatory environment.
- Exposure to multiple markets (EU, SA, ANZ).
- Skill development in CMC documentation and strategy.
- Collaborative work environment with experienced RA professionals.
How to Apply
