EU Regulatory Affairs Specialist — eCTD & CMC Expert

Barrington James; Eindhoven; On-site; EUR 60,000 - 90,000; Full time

Job summary

Barrington James is partnering with a growing pharmaceutical consultancy in the Netherlands to recruit an experienced Regulatory Affairs professional. The role covers a broad range of regulatory projects from early development to commercialization, with emphasis on CMC, eCTD submissions and translational development. You will coordinate EU submissions and interact with multiple teams across Europe.

Qualifications

• 3–8 years of Regulatory Affairs experience.
• Strong hands-on eCTD and regulatory dossier experience.
• Pharmaceutical, biotech or consultancy background.
• Good understanding of European regulatory procedures.
• Strong stakeholder and project management skills.

Responsibilities

• Prepare, compile and review eCTD regulatory submissions.
• Author and review CMC documentation.
• Support variations, renewals and lifecycle management.
• Coordinate EU submissions across Centralised, Decentralised and National procedures.
• Prepare responses to regulatory authority questions and deficiency letters.
• Support regulatory strategy across different development stages.
• Collaborate with Quality, Clinical, Non-Clinical, Manufacturing and Regulatory teams.

Skills

Regulatory affairs

eCTD experience

CMC documentation

Stakeholder management

Project management

Job description

Barrington James is partnering with a growing pharmaceutical consultancy in the Netherlands to recruit an experienced Regulatory Affairs professional. The role covers a broad range of regulatory projects from early development to commercialization, with emphasis on CMC, eCTD submissions and translational development. You will coordinate EU submissions and interact with multiple teams across Europe.