Senior Director Regulatory Affairs Europe – Oncology

Job Description

This is a highly visible leadership role at the forefront of Oncology Regulatory Affairs, offering the opportunity to shape regional regulatory strategy, develop talent, and drive impact for patients across Europe. If you are passionate about science, leadership, and bringing innovative cancer medicines to patients, we would love to hear from you.

Purpose of the position

We are seeking an experienced Senior Director to lead a team within our Oncology Regulatory Affairs Europe organization. In this role, you will be responsible for developing and executing regulatory strategies across Europe, the UK, Switzerland and selected non-EU markets for a complex and broad oncology portfolio. You will lead a team of Regulatory Affairs professionals and act as a key strategic partner to regional and global stakeholders.

Welcome to our team

Regulatory Affairs Europe is part of Global Regulatory Affairs and Clinical Safety (GRACS). Our mission is to bring innovative medicines to patients as efficiently as possible while ensuring compliance with regulatory requirements across the region. Within Oncology, we support one of the most dynamic and strategically important portfolios in the company. Working across Europe and beyond, we collaborate closely with global, regional and local stakeholders to advance breakthrough therapies and improve outcomes for patients with cancer.

Key Responsibilities

• Develop and execute regulatory strategies across the EU and selected non-EU markets to achieve timely approvals and optimal product labeling.
• Lead complex regulatory submissions and approval procedures, including Paediatric Investigation Plans (PIPs), Orphan Drug Designation (ODD), Scientific Advice, and EU registration procedures, while supporting Clinical Trial Applications (CTAs) under the EU Clinical Trial Regulation and Joint Clinical Assessments (JCAs) under the EU HTA Regulation.
• Serve as the key liaison with health authorities, Country Regulatory Affairs teams, and cross-functional stakeholders.
• Provide strategic regulatory guidance to Global Regulatory Affairs, development teams, and the commercial organization.
• Ensure regulatory compliance, lifecycle management, and final approval of regulatory submissions within the assigned therapeutic area.
• Lead people, projects, and process improvement initiatives to support business objectives and regulatory excellence.

Your profile

• PhD, PharmD, MD or Master's degree in Life Sciences or a related scientific discipline.
• Significant experience in Regulatory Affairs within the pharmaceutical industry.
• Experience within Oncology or in another complex therapeutic area with strong strategic regulatory exposure.
• Strong experience with European regulatory procedures and EMA interactions.
• Demonstrated experience developing and executing regulatory strategies for complex products.
• Proven leadership and people management experience.
• Excellent written, verbal and interpersonal communication skills.
• Ability to influence stakeholders across a matrix organization and operate effectively in a global environment.

What we offer

Our benefits are highly competitive and designed to support your professional growth, financial well-being, and personal lifestyle.

• Competitive base salary aligned with your expertise and experience.
• Performance-related incentive plans, including annual bonuses based on individual and company results.
• Generous annual leave/vacation policy to support a healthy work-life balance.
• Competitive company pension scheme to help secure your financial future.
• Modern, accessible office locations with excellent commuting options and facilities.

Required Skills

Biopharmaceutical Industry, Clinical Judgment, Clinical Risk Management, Compliance Investigations, Oncology, People Management, Regulatory Affairs Compliance, Regulatory Communications, Regulatory Submissions, Strategic Planning