Director, Global Regulatory Affairs

Biopharma Careers; Billerica (MA); On-site; USD 172,000 - 231,000; Full time

Benefits offered by this job

Health insurance

PTO

Retirement contributions

Perquisites

Job summary

EMD Serono seeks a Director of Global Regulatory Affairs to define and execute the global regulatory strategy for oncology programs, leading cross-functional teams and coordinating with major health authorities.

You will mentor staff, oversee submissions across regions, and ensure compliance with global regulations from our Billerica, MA site. English proficiency and strategic leadership are essential for success.

Qualifications

• Advanced degree (e.g., PhD, PharmD, MD, or equivalent).
• At least 6 years of regulatory experience with at least 3 years in Oncology.
• Demonstrated track record in strategy development and HA/EMA/FDA interaction.

Responsibilities

• Develop and execute global regulatory strategy for oncology programs.
• Lead regulatory submissions and lifecycle management across regions.
• Manage interactions with health authorities (FDA, EMA) to facilitate approvals.
• Provide strategic regulatory input to portfolio teams; data-driven decisions.

Skills

Regulatory strategy

HA/EMA/FDA interactions

Cross-functional leadership

English proficiency

Project management

Stakeholder management

Education

Advanced degree (PhD/PharmD/MD)

Tools

eCTD submissions

Job description

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 Director of Global Regulatory Affairs is responsible for defining and executing the global regulatory strategy for designated oncology programs, ensuring timely and compliant approvals across geographies. This role requires strong leadership in cross-functional teams and deep expertise in regulatory interactions with major health authorities.

Key accountabilities

• Develop and execute global regulatory strategy for oncology programs within the Oncology TA.
• Lead regulatory submissions and life-cycle management across multiple regions in collaboration with the global regulatory team.
• Manage and optimize interactions with health authorities (e.g., FDA, EMA) to facilitate approvals and label extensions.
• Provide strategic regulatory input to portfolio and program teams; influence decision-making with a data-driven approach.
• Lead a cross-functional, matrix-driven team to align on regulatory requirements, timelines, and deliverables.
• Ensure compliance with global/regional regulations, quality standards, and internal governance.
• Mentor and develop junior regulatory colleagues; foster a culture of regulatory excellence and proactive risk management.
• Monitor evolving regulatory landscape to anticipate impact on programs and adapt strategies accordingly.
• Collaborate with global patients- and science-focused teams to support program milestones and lifecycle planning.

Required background and qualifications

• Advanced degree (e.g., PhD, PharmD, MD, or equivalent).
• At least 6 years of relevant regulatory experience with at least 3 years in Oncology.
• Demonstrated track record as an effective strategy developer and HA/EMA/FDA interaction expert.
• Proven ability to lead in a matrixed, cross-functional environment.
• Strong written and spoken English communication skills; proficiency in other languages is a plus.
• Excellent project management and influencing skills; able to drive programs across complex organizations.

Desired skills and attributes

• Strategic thinker with a hands-on, execution-focused mindset.
• Strong stakeholder management and negotiation capabilities.
• Ability to manage competing priorities with a clear gaze on risk management and compliance.
• Experience with global regulatory submissions (eCTD/dossier delivery) and lifecycle planning.
• Patient-centric mindset and commitment to scientific rigor.

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

Pay Range for this position: $171,600 - $230,900. 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.

For more information click here: https://careers.emdgroup.com/us/en/benefits

What we offer: We're 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!