Regulatory Affairs Manager (CMC)

Responsibilities

• Generate and execute global and country-specific regulatory CMC strategies
• Provide CMC regulatory strategy for assigned projects by defining filing requirements, submission strategies, and risk assessments
• Develop global dossiers for CMC content for initial submissions, variations, and amendments
• Support change management activities and develop response strategies for health authority questions
• Liaise with development, operations, and commercial functions to ensure alignment of global regulatory strategies and supply plans
• Coordinate with local regulatory teams to align on filing strategies
• Monitor and maintain submission information within the Regulatory Information Management (RIM) system

Requirements

• Doctorate degree OR Master’s degree with 3 years of directly related experience OR Bachelor’s degree with 5 years of directly related experience
• Deep CMC-specific regulatory knowledge and experience
• Experience in manufacture, testing (QC/QA or clinical), or distribution
• Proven experience in Regulatory CMC

About the Company

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. A biotechnology pioneer since 1980, Amgen leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives.