Job Description – CMC Variations SpecialistExperience: 2–4 yearsLocation: 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.
Job Title
Regulatory Affairs Specialist - CMC Variations (Junior level)