Senior Director, Global Regulatory Affairs

The businesses of Merck KGaA, Darmstadt, Germany•Billerica, MA

1d•$221,600 - $305,400•Hybrid

About The Position

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. The role involves directing and coordinating regulatory strategy across a portfolio of oncology projects, leading global regulatory submissions, lifecycle management, and interactions with health authorities like the FDA and EMA. The position also requires aligning regional and global regulatory plans, mentoring and developing staff, driving talent recruitment, managing risks and timelines, and collaborating with cross-functional partners. The company emphasizes a culture of innovation, diversity, and inclusion, aiming to improve and prolong lives through its healthcare solutions.

Requirements

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.

Nice To Haves

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.

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.