Executive Director, Global Regulatory Affairs

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 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 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 Onsite role based in our Billerica, MA facility requiring onsite presence at least 3 days per week. Pay Range and Benefits Pay Range: $221,600 - $305,400. Benefits include health insurance, paid time off (PTO), retirement contributions, and other perquisites. Compensation may also include sales or performance-based bonuses. What We Offer We are committed to creating access and opportunities for all to develop and grow at your own pace. We build a culture of inclusion and belonging that empowers everyone to work their magic and champion human progress. #J-18808-Ljbffr EMD Serono, Inc.