Executive Director, Global Regulatory Affairs

About the role

Oversee 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.

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.

Requirements

• Advanced degree (e.g., PhD, PharmD, MD) or equivalent experience.
• At least 12 years of relevant regulatory experience.
• At least 5 years of 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.

Skills

• 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 Billerica, MA, requiring an onsite presence at least 3 days per week.

Pay

Pay range for this position: $221,600 - $305,400. 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

• Health insurance
• Paid time off (PTO)
• Retirement contributions
• Other perquisites

For more information, visit EMD Group Benefits.