Regulatory Affairs Manager

We are seeking a Regulatory Affairs professional to join a growing pharmaceutical consultancy supporting innovative biotech and pharmaceutical clients across Europe.

This position offers exposure to a broad range of regulatory activities spanning early development through commercialization, with a particular focus on CMC documentation, eCTD submissions, and translational development programs.

The successful candidate will work closely with cross-functional teams, including Quality, Clinical, Non-Clinical, Manufacturing and Regulatory Affairs, supporting clients in navigating complex European regulatory requirements.

Key Responsibilities

Prepare, compile, review and maintain regulatory dossiers and submissions in eCTD format.

Author and review CMC documentation for regulatory submissions, variations, renewals and lifecycle management activities.

Support translational development activities, ensuring alignment between non-clinical, clinical and CMC development strategies.

Coordinate regulatory submission activities across EU procedures including Centralised, Decentralised and National pathways.

Prepare and manage responses to regulatory authority questions and deficiency letters.

Collaborate with internal and external stakeholders including pharmaceutical companies, biotech firms, CMOs and regulatory agencies.

Support regulatory strategy development for products across various stages of development.

Ensure regulatory documentation remains compliant with current EMA and national authority requirements.

Maintain awareness of evolving European regulatory guidance and industry trends.

Candidate Profile

Bachelor's, Master's or equivalent degree in Pharmacy, Biopharmacy, Life Sciences, Biotechnology or a related scientific discipline.

3–8 years of Regulatory Affairs experience within pharmaceutical, biotechnology or consultancy environments.

Strong hands‑on experience with eCTD submissions and regulatory dossier management.

Experience authoring and reviewing CMC documentation for pharmaceutical or biologic products.

Exposure to translational development activities and early‑stage product development is highly desirable.

Good understanding of European regulatory frameworks and submission procedures.

Strong project management and stakeholder management skills.

Excellent written and verbal communication skills in English.

Ability to work independently while managing multiple client projects simultaneously.

Preferred Experience

Experience supporting biologics, advanced therapies or innovative pharmaceutical products.

Previous consultancy experience.

Familiarity with GMP principles and pharmaceutical manufacturing processes.

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