At a Glance
- Tasks: Lead regulatory strategy for innovative medicines in Immunology & Cardiovascular fields across Europe.
- Company: Bristol Myers Squibb, a purpose-driven company transforming patient lives.
- Benefits: Comprehensive benefits, supportive environment, and opportunities for growth.
- Other info: Collaborative culture with flexible work models and commitment to inclusion.
- Why this job: Make a real impact on patients' lives by shaping the future of medicine.
- Qualifications: Strong scientific background and extensive regulatory affairs experience required.
The predicted salary is between 63000 - 77000 £ per year.
At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.
Are you a seasoned regulatory strategist ready to drive cutting-edge medicines through the European approval landscape? At BMS, we're looking for a bold, scientifically grounded Director, European Regulatory Strategy Lead to champion our Immunology & Cardiovascular (ICV) portfolio — from early development all the way through registration and lifecycle management. This is your opportunity to sit at the heart of strategy, directly influencing how transformative therapies reach patients across Europe.
What You'll Do
- As the European Regulatory Lead (ERL), you'll be the regulatory compass for your assigned Development Team(s), with the EU as your primary focus.
- Define and drive EU regulatory strategy across development, registration, and lifecycle management.
- Lead negotiations with the EMA and other relevant Health Authorities, translating BMS strategy into real outcomes.
- Build integrated submission plans and translate them into operational deliverables for internal teams and external partners.
- Integrate scientific, medical, legal and business perspectives to achieve optimal regulatory outcomes.
- Provide authoritative regulatory guidance to Development Team Leaders and cross-functional stakeholders, proactively resolving complex issues.
- Monitor and anticipate evolving European and international regulatory trends, positioning BMS ahead of the curve.
- Build and nurture strong relationships with Health Authorities, alliance partners, and EU country colleagues.
What You'll Bring
- A strong scientific/medical background — Ph.D., M.D., PharmD, MSc, or BSc in a relevant discipline.
- Extensive experience in regulatory affairs, with proven success delivering global/EU regulatory strategies.
- Prior experience in immunology and/or cardiovascular therapeutic areas (industry, health authority, or drug development) is preferred.
- A track record of successful Health Authority negotiations, including with the EMA.
- Experience leading cross-functional matrix teams in a complex, matrixed environment.
- Excellent written and verbal communication skills — you make the complex clear.
Key Competencies
- Deep understanding of EU regulatory principles and procedures.
- Ability to integrate scientific, regulatory, and business thinking into practical, executable strategies.
- Resilient and decisive under pressure — you're comfortable navigating risk and driving resolution.
- A collaborative team player who works seamlessly across organisational, functional, and geographic boundaries.
Travel required as appropriate.
How We Work
Where you work matters – because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities.
Supporting People with Disabilities
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer.
Director, Regulatory Strategy Lead Europe employer: Bristol Myers Squibb
At Bristol Myers Squibb, we offer a unique opportunity for Integrated Healthcare Managers to engage in meaningful work that truly transforms lives. Our supportive culture fosters professional growth and innovation, while our competitive benefits ensure a healthy work-life balance. Join us in the South UK, where you can thrive in a dynamic environment alongside passionate colleagues dedicated to making a real difference in the field of haematology-oncology.
StudySmarter Expert Advice🤫
We think this is how you could land Director, Regulatory Strategy Lead Europe
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We think you need these skills to ace Director, Regulatory Strategy Lead Europe
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 Bristol Myers Squibb!
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 Bristol Myers Squibb 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 Bristol Myers Squibb!
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 Bristol Myers Squibb, 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 Bristol Myers Squibb
✨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 Bristol Myers Squibb that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
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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 Bristol Myers Squibb’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.
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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.
