At a Glance
- Tasks: Lead regulatory strategies for innovative oncology medicines across Europe and beyond.
- Company: Join a leading biopharmaceutical company dedicated to improving cancer patient outcomes.
- Benefits: Competitive salary, performance bonuses, generous leave, and a solid pension scheme.
- Other info: Flexible hybrid work arrangements and modern office locations.
- Why this job: Make a real impact in oncology while developing your leadership skills in a dynamic environment.
- Qualifications: PhD, PharmD, MD or Master's in Life Sciences with significant regulatory experience.
The predicted salary is between 63000 - 77000 £ per year.
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.
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.
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.
- 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.
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.
Senior Director Regulatory Affairs Europe – Oncology employer: Merck Sharp & Dohme (MSD)
Join a leading biopharmaceutical company that prioritises innovation and patient impact in the oncology sector. With competitive salaries, performance-related bonuses, and a strong focus on employee development, we foster a collaborative work culture across our modern offices in Oss, London, Brussels, Spain, and Switzerland. Here, you will have the opportunity to lead a talented team while contributing to groundbreaking therapies that improve patient outcomes.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Director Regulatory Affairs Europe – Oncology
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We think you need these skills to ace Senior Director Regulatory Affairs Europe – Oncology
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at Merck Sharp & Dohme (MSD)!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show Merck Sharp & Dohme (MSD) that you're not just a fit for the job but also a safety-conscious candidate!
Tailor Your CV to Be Result-Driven:Craft your CV to highlight quantifiable achievements, especially if you have previous roles in pharmaceuticals or related fields. Use metrics to demonstrate your impact, such as improved processing times or successful project completions while working on trials. This analytical approach will resonate well with hiring managers at Merck Sharp & Dohme (MSD)!
Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At Merck Sharp & Dohme (MSD), we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at Merck Sharp & Dohme (MSD)
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at Merck Sharp & Dohme (MSD) that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
✨Showcase Relevant Experience
If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
✨Know Their Products
Take some time to familiarise yourself with Merck Sharp & Dohme (MSD)’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.
✨Be Ready for Regulatory Scenarios
In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
