Regulatory Affairs Specialist

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

Regulatory Affairs Consultant | Netherlands | Permanent

I’m currently working with a growing pharmaceutical consultancy supporting innovative biotech and pharmaceutical companies across Europe, and they’re looking to add an experienced Regulatory Affairs professional to the team.

This is a great opportunity for someone who wants exposure to a broad range of regulatory projects - from early-stage development through to commercialization - with a strong focus on CMC, eCTD submissions and translational development.

What you’ll be doing:

• Preparing, compiling and reviewing eCTD regulatory submissions
• Authoring and reviewing CMC documentation
• Supporting variations, renewals and lifecycle management
• Coordinating EU submissions across Centralised, Decentralised and National procedures
• Preparing responses to regulatory authority questions and deficiency letters
• Supporting regulatory strategy across different stages of development
• Working closely with Quality, Clinical, Non-Clinical, Manufacturing and Regulatory teams
• Managing multiple client projects across pharmaceutical and biotech programs

What they’re looking for:

• 3–8 years’ 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

Ideally, you’ll also have:

• Biologics, advanced therapies or innovative pharmaceutical experience
• GMP/manufacturing knowledge
• Experience engaging with European regulatory authorities