Regulatory Affairs Manager EU

About the role

Join a leading global biotechnology organisation as a Regulatory Affairs Manager for the European region. You will support the development, approval and life‑cycle management of innovative medicines across multiple therapeutic areas, from early clinical trials to post‑marketing activities.

Key responsibilities

• Plan, prepare and manage regulatory submissions, including clinical trial applications and marketing authorisation dossiers.
• Support the implementation of regional regulatory strategies for a diverse portfolio of development and commercial products.
• Provide regulatory expertise to cross‑functional teams on European requirements and pathways.
• Develop regulatory documentation and liaise with health authorities.
• Advise on mechanisms that accelerate development such as orphan designation, fast‑track pathways, paediatric plans and compassionate‑use programmes.
• Support labelling activities and negotiations with agencies.
• Assess regulatory risks and opportunities to shape product and life‑cycle strategies.
• Monitor legislative and guideline changes and evaluate their impact.
• Conduct regulatory research, analyse precedent cases and track competitor activities.

Required profile

• Degree in a scientific discipline, life sciences or a related field.
• Previous experience in regulatory affairs within the pharmaceutical or biotechnology industry.
• Strong understanding of European procedures for clinical trials and marketing authorisations.
• Knowledge of medicinal product regulations and relevant pathways.

Required skills