Regulatory Affairs Specialist

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

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