Senior Manager in CMC Regulatory Affairs

Elevate your career with Indegene as a Senior Manager in CMC Regulatory Affairs. This role combines team leadership and expert consulting within a flexible work environment.
Indegene is looking for a Senior Manager specializing in CMC Operations and Writing, requiring a robust educational foundation and significant experience. You will manage a growing writing team while acting as a key consultant for CMC strategic initiatives. Your extensive background in regulatory expectations will be essential for effective delivery.
Key Responsibilities:
• Mentor and enhance a global CMC writing team
• Act as a senior subject matter expert in client engagements
• Ensure compliance and timely delivery of CMC documentation
• Participate in leading project scope discussions
• Collaborate with cross-functional teams for streamlined operations
Requirements:
• Bachelor’s and Master’s degree in Chemistry or Pharmacy
• 16–18 years of experience in CMC operations
• Proven m...