Director, Global Regulatory Affairs

EMD Serono Research & Development Institute•Billerica, MA

7d•$171,600 - $230,900•Onsite

About The Position

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.

Requirements

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.

Nice To Haves

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.

Responsibilities

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.