CMC Regulatory Affairs Lead — Global Submissions

Amgen SA

Breda

On-site

EUR 90,000 - 130,000

Full time

14 days+

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Job summary

Amgen Breda seeks a Regulatory Affairs Manager to translate CMC regulatory requirements into practical plans. You will manage site changes, coordinate with global authorities, and lead regulatory submissions for new marketing applications and post-market changes.

The role requires strong leadership, English and Dutch communication, and experience in QA/RA within pharma/biotech. Enjoy a dynamic, global team environment with extensive collaboration across sites.

Qualifications

Doctorate or Master’s with 3+ years in QA/Regulatory Affairs in pharma/biotech.
Bachelor’s with 5+ years in quality, process development or regulatory affairs.
Background in biology, biotech, microbiology or chemistry.

Responsibilities

Support development and implementation of regulatory strategies related to site changes.
Lead submission processes for site initiatives.
Provide regulatory expertise for manufacturing related projects.
Coordinate with regulatory authorities with global/regional representations.
Support inspections and act as RA-CMC representative on cross functional teams.
Contribute to creation of site-related regulatory components for global submissions.
Assist in generating facility and GMP documents for registrations.
Review and approve regulatory documents.
Assess regulatory impact of manufacturing changes and deviations.