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. The preferred locations for this role are Oss (NL), London (UK), Brussels (BE), Spain or Switzerland. 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

• Develops and executes regulatory strategies across the EU and selected non-EU markets to achieve timely approvals and optimal product labeling.
• Is responsible for 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.
• Serves as the key liaison with health authorities, Country Regulatory Affairs teams, and cross-functional stakeholders.
• Provides strategic regulatory guidance to Global Regulatory Affairs, development teams, and the commercial organization.
• Ensures regulatory compliance, lifecycle management, and final approval of regulatory submissions within the assigned therapeutic area.
• Leads people, projects, and process improvement initiatives to support business objectives and regulatory excellence.

Your profile

• PhD, PharmD, MD or Masters 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. While specific packages may vary slightly depending on your primary work location, you can generally expect:

• A 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
• A solid, 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

Preferred Skills:

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Current Contingent Workers applyHERE

Search Firm Representatives Please Read Carefully

Merck Co., Inc., Rahway, NJ, USA, also known as Merck Sharp Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

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Hazardous Material(s):

Job Posting End Date:

09/4/2026*A job posting is effective until 11:59:59PM on the dayBEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFORE the job posting end date.

Requisition ID: R408963