Regulatory Affairs Manager – CMC

About the role

The Regulatory Affairs Manager (CMC) will lead the development and execution of chemistry, manufacturing and controls (CMC) regulatory strategies for products manufactured at Amgen sites. You will work closely with cross‑functional teams to ensure compliance with federal, state and local regulations and to support global product submissions.

Key responsibilities

• Define CMC regulatory filing requirements, submission strategies and risk assessments for assigned projects.
• Support the creation of global dossiers for new marketing applications (MAA), clinical trial applications (CTA), variations and amendments.
• Prepare and maintain post‑approval submissions and manage change‑control regulatory assessments.
• Respond to regulatory agency questions and provide regulatory input on product deviation investigations.
• Liaise with Global RA CMC product leads, ROOTS representatives and other functions to align strategies and timelines.
• Track and update departmental deliverables in internal systems.
• Participate actively in cross‑functional project teams.

Required profile

• Proven experience in regulatory affairs with a focus on CMC.
• Strong knowledge of regulatory submission processes for MAAs, CTAs and variations.
• Ability to work collaboratively with R&D, operations and commercial teams.
• Understanding of change management and post‑approval lifecycle activities.

Required skills

• Regulatory submissions (MAA, CTA, variations)
• Chemistry, Manufacturing and Controls (CMC) expertise
• Change Management processes

What we offer

• Opportunity to work in a global biotechnology leader.
• Collaboration with remote teams across the US, Ireland, the Netherlands and Puerto Rico.
• Impactful work that directly supports patient care worldwide.