Senior Director, Global Regulatory Strategy

Description of Role

As the Senior Director, Global Regulatory Strategy you will report to the VP, Regulatory and Medical Writing and serve as a key member within our regulatory team, providing strategic and operational regulatory leadership across global development programs. As the Regulatory Lead for assigned assets, you will develop and execute global regulatory strategies spanning nonclinical, clinical, and registration activities, including leading NDA planning, preparation, and submission efforts. The role requires extensive experience leading global regulatory programs and managing interactions with health authorities, including the FDA and other international regulatory agencies. In partnership with cross-functional development teams, you will provide regulatory guidance, lead regulatory sub-teams, and align stakeholders to support successful program advancement from development through registration. This position also requires prior direct people management experience, success operating within a matrixed organization, and the ability to oversee external regulatory consultants and vendors while driving regulatory excellence across the portfolio.

Key Responsibilities

• Serve as the Global Regulatory Lead for assigned development programs, providing strategic regulatory leadership from early development through registration and lifecycle management.
• Develop and execute global regulatory strategies to obtain, maintain, and expand product registrations across multiple regions and health authorities.
• Lead the planning, preparation, and submission of major regulatory filings, including INDs, NDAs, briefing documents, and other regulatory submissions within scope of responsibility.
• Represent the company in regulatory interactions and lead meetings with global health authorities, including the FDA and other international regulatory agencies.
• Provide regulatory guidance and strategic input to cross-functional program teams, ensuring regulatory considerations are integrated into development plans and key business decisions.
• Lead regulatory sub-teams and represent Regulatory Affairs on cross-functional governance and program teams, driving alignment among internal stakeholders and senior leadership.
• Manage, develop, and mentor regulatory staff, fostering professional growth and building organizational capability within the Regulatory Affairs function.
• Ensure ongoing compliance with applicable regulatory requirements and guidance, communicating regulatory developments and implications to relevant stakeholders.
• Partner with the VP, Regulatory and Medical Writing and broader Regulatory Affairs leadership to strengthen departmental capabilities, operational excellence, and efficient execution across the portfolio.
• Identify, engage, and oversee external regulatory consultants and vendors to support the successful execution of regulatory strategies and submissions.

Qualifications

• Bachelor's degree in a scientific discipline with 12+ years of progressive regulatory affairs experience within the pharmaceutical or biotechnology industry, including 5+ years in a global regulatory leadership role.
• Advanced degree (PhD, PharmD, MS, or JD) and experience supporting small molecule development strongly preferred.
• Significant NDA leadership experience, including direct responsibility for NDA strategy, submission, and regulatory review activities in a sponsor organization.
• Must have recent significant experience with regulatory submission strategy, structure, and content, including NDAs, INDs, CTAs, and other global regulatory filings.
• Demonstrated track record of successful regulatory interactions with the FDA, EMA, and other global health authorities supporting major submissions and product approvals.
• Proven success serving as the Global Regulatory Lead for development and registration-stage programs within a matrixed environment, including direct people management experience.
• Extensive knowledge of nonclinical and clinical drug development, FDA, ICH, EMA, EU National Competent Authority, MHRA, and other applicable global regulatory requirements and guidelines.
• Strong experience leading cross-functional teams and providing strategic regulatory guidance to development programs from early development through registration and lifecycle management.
• Excellent written, verbal, presentation, and influencing skills, with the ability to communicate complex regulatory strategies and risks to senior management, health authorities, consultants, and external partners.
• Proven analytical, problem-solving, organizational, negotiation, and decision-making skills, with the ability to develop regulatory strategies and compelling, data-driven regulatory narratives.
• Demonstrated ability to thrive in a fast-paced, innovative environment while fostering collaboration, open communication, and alignment among diverse stakeholders.

Compensation

The annual base salary range for this position is $225,000.00 to $275,000.00. Individual compensation within this range will be determined based on a variety of factors, including qualifications, skills, relevant experience, job knowledge and location.

In addition to base pay, this role is eligible for a discretionary annual bonus. The Company also offers a comprehensive benefits package, which includes a 401(k) plan, company-sponsored medical, dental, vision, and life insurance, generous paid time off, and a health and wellness program.

Work Location

The Senior Director, Global Regulatory Strategy role is based in the US, with occasional travel.

POSITION: Full-Time, Exempt