Strategic Regulatory Affairs Manager, CMC & Submissions

Amgen Inc. (IR); Netherlands; Remote; EUR 90,000 - 130,000; Full time

Job summary

Amgen Breda is seeking a Regulatory Affairs Manager to translate CMC regulatory requirements into practical plans. You will support site-specific CMC sections for new marketing applications and post-market changes, coordinating with global regulators and internal teams.

The role requires a Doctorate/Master’s with regulatory experience or a Bachelor’s with extensive QA/Regulatory experience, strong leadership, and fluent English and Dutch.

Qualifications

• Doctorate or Master’s with 3+ years in QA/Regulatory Affairs in pharma/biotech, or Bachelor's with 5+ years in same.
• Educational background in Biology, Biotechnology, Microbiology or Chemistry.
• Experience managing change control and regulatory submissions.
• Strong English and Dutch communication.
• Ability to operate in a fast-paced environment and lead timelines.

Responsibilities

• Support development and implementation of regulatory strategies for site changes.
• Lead submission process for site initiatives.
• Provide regulatory strategy for manufacturing projects.
• Collaborate with Regulatory Authorities and global/regional teams.
• Support regulatory authority inspections as required.
• Serve as RA-CMC representative on cross-functional teams.
• Lead or contribute to global submissions for site-related regulatory components.
• Prepare facility and GMP documents for product registrations.
• Review and approve regulatory documents.
• Assess regulatory impact of changes, deviations and GMP documents.
• Maintain facility-related files.
• Develop regulatory awareness through meetings and conferences.

Skills

Leadership

Regulatory submissions

Change control

English & Dutch communication

Education

Doctorate or Master’s + Regulatory Affairs experience

Bachelor’s degree + Regulatory Affairs experience

Job description

Amgen Breda is seeking a Regulatory Affairs Manager to translate CMC regulatory requirements into practical plans. You will support site-specific CMC sections for new marketing applications and post-market changes, coordinating with global regulators and internal teams.

The role requires a Doctorate/Master’s with regulatory experience or a Bachelor’s with extensive QA/Regulatory experience, strong leadership, and fluent English and Dutch.