Regulatory Affairs Manager (CMC)
Amgen · Hyderabad, India
RegulatoryFull-timeCompany career page
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Role summary
Amgen seeks a Regulatory Affairs CMC Manager to oversee global regulatory chemistry, manufacturing, and controls activities for commercial products. The role involves developing regulatory strategies, managing submissions, and coordinating cross-functional collaboration across sites and regions.
What they're looking for
- Doctorate degree OR Master's degree with 3+ years related experience OR Bachelor's degree with 5+ years related experience
- CMC-specific regulatory knowledge and direct experience
- Background in manufacturing, QC/QA testing, or clinical testing
- Experience with regulatory submissions and CMC strategy development
- Knowledge of health authority requirements and regulatory guidance
What you'll be doing
- Generate and execute global and country-specific CMC regulatory strategies
- Define filing requirements, submission strategy, and regulatory risk assessments for assigned projects
- Develop global dossiers for CMC content in initial submissions, variations, and amendments
- Respond to health authority questions and manage regulatory change activities
- Coordinate with development, operations, and commercial teams to align global strategies and execution timelines
Privacy & handoff
This role links to Amgen's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.