Director, Global Regulatory Affairs
Merck•Billerica, MA
•Onsite
About The Position
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.
Benefits
- health insurance
- paid time off (PTO)
- retirement contributions
- other perquisites
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
Upload and Match Resume
What This Job Offers
Job Type
Full-time
Career Level
Director
