Regulatory Affairs Manager - CMC & Global Submissions

Amgen; Netherlands; On-site; EUR 90,000 - 130,000; Full time

Benefits offered by this job

Total Rewards Plan

On-site gym

Restaurant with healthy food

Holiday allowance

Job summary

Amgen Breda is seeking a Regulatory Affairs Manager to translate CMC regulatory requirements into practical plans and lead site submissions for initiatives. You will act as RA-CMC liaison with global authorities and cross-functional teams to ensure compliant changes.

The role requires a strong background in Regulatory Affairs within pharma/biotech, with English and Dutch proficiency, and demonstrated leadership in managing timelines and inspections.

Qualifications

• Doctorate or Master's degree with 3+ years in Quality, Process Development, Validations or Regulatory Affairs in Pharma/Biotech
• Bachelor's with 5+ years in Quality, Process Development, Validations or Regulatory Affairs in Pharma/Biotech
• Educational background in Biology, Biotechnology, Microbiology or Chemistry
• Experience with change control and regulatory submissions
• Strong English and Dutch oral and written communication; leadership and project timing skills

Responsibilities

• Translate CMC regulatory requirements into practical plans
• Lead site submission processes for initiatives
• Provide regulatory expertise for manufacturing related projects
• Collaborate with Regulatory Authorities and global/regional teams
• Support regulatory inspections and site documentation
• Review and approve regulatory documents
• Maintain facility GMP-related files

Skills

Regulatory Affairs

Change control

Project management

Communication (English & Dutch)

Leadership

Education

Doctorate or Master's degree

Bachelor's degree

Job description

Amgen Breda is seeking a Regulatory Affairs Manager to translate CMC regulatory requirements into practical plans and lead site submissions for initiatives. You will act as RA-CMC liaison with global authorities and cross-functional teams to ensure compliant changes.

The role requires a strong background in Regulatory Affairs within pharma/biotech, with English and Dutch proficiency, and demonstrated leadership in managing timelines and inspections.