Regulatory Affairs Manager, CMC Strategy

Amgen; Breda; On-site; EUR 90,000 - 120,000; Full time

Job summary

Amgen Breda is seeking a Regulatory Affairs Manager to translate CMC regulatory requirements into practical plans and lead site-specific submissions. The role includes coordinating post-market changes and regulatory communications with global authorities.

You will drive change control, support inspections, and work with manufacturing, quality and regulatory teams. Fluency in English and Dutch and strong leadership are essential.

Qualifications

• Doctorate or Master’s degree with 3+ years of Quality, Process Development, Validations and/or Regulatory Affairs experience in Pharma/Biotech.
• Bachelor’s degree with 5+ years of Quality, Process Development, Validations and/or Regulatory Affairs experience in Pharma/Biotech.
• Educational background in Biology, Biotechnology, Microbiology or Chemistry.
• Experience managing change control and regulatory submissions.
• Strong oral and written communication in English and Dutch.

Responsibilities

• Support the development and implementation of regulatory strategies for site changes.
• Lead submission processes for site initiatives.
• Provide regulatory expertise for manufacturing-related projects.
• Collaborate with Regulatory Authorities and Global/International teams.
• Support regulatory authority inspections as required by Site Quality Compliance.
• Serve as RA-CMC representative on Cross Functional Teams.
• Lead or contribute to site regulatory components for global submissions.
• Support generation of facility and GMP documents for product registrations.

Skills

Leadership

Regulatory submissions

Change control

Cross-functional collaboration

Project management

English & Dutch communication

Education

Doctorate/Master's with 3+ years in QA/Regulatory

Bachelor's with 5+ years in QA/Regulatory

Biology/Biotechnology/Microbiology/Chemistry background

Job description

Amgen Breda is seeking a Regulatory Affairs Manager to translate CMC regulatory requirements into practical plans and lead site-specific submissions. The role includes coordinating post-market changes and regulatory communications with global authorities.

You will drive change control, support inspections, and work with manufacturing, quality and regulatory teams. Fluency in English and Dutch and strong leadership are essential.