Senior Director, Drug Development

About the role

The Senior Director, Drug Development will lead regulatory strategy and execution for oncology-focused biopharmaceutical projects. Working remotely from anywhere in Europe, you will guide customers through IND, NDA/BLA, and MAA submissions while ensuring alignment with US and European regulatory frameworks.

Key responsibilities

• Provide strategic leadership for all regulatory submissions, including INDs, NDAs, BLAs, MAAs and special designations such as orphan drug and fast‑track status.
• Represent customers in interactions with FDA, EMA and other authorities across the full product lifecycle.
• Lead and develop a global regulatory team, handling line‑management and performance coaching.
• Assess regulatory risk, support indication prioritisation, due‑diligence and gap‑analysis activities.
• Shape product development strategies from discovery to market, contributing to Target Product Profiles, Clinical Development Plans and study designs.
• Deliver high‑quality, data‑driven deliverables that meet medical, ethical and scientific standards.

Required profile

• Extensive experience in regulatory affairs for drugs, biologics or advanced therapies, preferably in oncology.
• Proven track record of successful IND, NDA/BLA and MAA submissions in the US and Europe.
• Strong leadership experience managing cross‑functional, multinational regulatory teams.
• Ability to communicate complex regulatory concepts to senior customer management.

Required skills

• Regulatory submissions (IND, NDA, BLA, MAA)
• FDA and EMA engagement
• Orphan drug, fast‑track and breakthrough designation processes
• Risk assessment and mitigation planning

What we offer

• Fully remote work based in Europe
• Opportunity to influence high‑impact oncology drug programs
• Collaborative environment with leading biopharma customers