Regulatory Affairs Manager – Oncology CTA

About the role

This contract position supports innovative oncology and advanced therapy programmes within a global biopharmaceutical environment. You will work closely with global and regional stakeholders to shape regulatory strategy and ensure timely submission of Clinical Trial Applications (CTA) and EU Clinical Trials Regulation (EU CTR) dossiers across Europe.

Key responsibilities

• Lead regulatory affairs activities for both development‑stage and marketed oncology products.
• Drive CTA submissions, substantial amendments and EU CTR activities throughout Europe.
• Develop and execute regulatory strategy in partnership with global regulatory teams.
• Prepare and coordinate regulatory submissions in line with EU and ICH requirements.
• Represent Regulatory Affairs on cross‑functional project teams and liaise with health authorities.
• Monitor evolving European regulatory requirements and provide strategic guidance to stakeholders.

Required profile

• Proven experience in Regulatory Affairs within the pharmaceutical or biotech sector.
• Strong knowledge of Clinical Trial Applications (CTA) and the EU Clinical Trials Regulation (EU CTR).
• Experience developing and executing regulatory strategy for clinical development programmes.
• Broad understanding of European regulatory requirements and procedures.
• Experience supporting interactions with health authorities and cross‑functional teams.
• Oncology, cell therapy, ATMP or advanced therapy experience is highly advantageous.

Required skills

• Clinical Trial Applications (CTA)
• EU Clinical Trials Regulation (EU CTR)
• ICH guidelines

What we offer

• 12‑month contract with the possibility of extension.
• Hybrid working model with flexibility for the right candidate.
• Opportunity to influence cutting‑edge oncology programmes and complex regulatory strategies.
• High‑impact role collaborating with regulatory, clinical development and global project teams.