Executive Director, Global Regulatory Affairs

Senior Director, Global Regulatory Affairs

Work Your Magic with us! Start your next chapter and join EMD Serono.

Ready to explore, break barriers, and discover more? We know you've got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

Position Scope:

The Senior Director, Global Regulatory Affairs oversees the regulatory strategy and execution for multiple oncology programs globally, ensuring timely submissions and successful approvals while leading and developing a high-performing regulatory team.

Key responsibilities include, but are not limited to the following:

• Direct and coordinate the regulatory strategy and execution across a portfolio of oncology projects.
• Lead global regulatory submissions, lifecycle management, and regulatory health authority interactions (FDA, EMA, etc.).
• Align regional and global regulatory plans to program milestones; ensure consistency across submissions and labeling.
• Mentor, coach, and develop staff; build and sustain a high-performing regulatory team.
• Drive talent recruitment and development within the regulatory function; foster a culture of compliance and scientific excellence.
• Manage risk, timelines, and resource planning; communicate program status to senior leadership.
• Stay abreast of evolving regulatory landscapes and integrate changes into portfolio planning.
• Collaborate with cross-functional partners (clinical, CMC, pharmacovigilance, medical affairs) to enable successful program outcomes.

Minimum requirements and qualifications include:

• Advanced degree (e.g., PhD, PharmD, MD) or equivalent experience.
• At least 12 years of relevant regulatory experience, with at least 5 years leading global oncology regulatory teams.
• Demonstrated track record of successful FDA and EMA interactions supporting major oncology submissions.
• Proven leadership of staff and regulatory teams in a matrix environment.
• Excellent spoken and written English; additional languages are a plus.

Desired skills and attributes

• Strategic thinker with strong execution capabilities.
• Superior stakeholder management, negotiation, and people-leadership skills.
• Deep experience in global regulatory submissions and lifecycle management.
• Ability to attract, develop, and retain regulatory talent.
• High adaptability to changing priorities and regulatory requirements.

Location: This is an onsite role based in our Billerica, MA facility requiring an onsite presence at least 3 days per week.

Pay Range for this position: $221,600 - $305,400. The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites.

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!

Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!