Senior Director Regulatory Strategy

Responsibilities

• Lead the regulatory strategy for multiple pharmaceutical development programs, from first-in-human clinical trials through FDA approval and post-market activities.
• Develop and execute global regulatory strategy that align with clinical development and overall business objectives.
• Provide strategic guidance on regulatory pathways, submission plans, and interactions with health authorities, including the FDA.
• Serve as the regulatory lead on cross-functional teams, partnering with Clinical, Medical, R&D, Quality, CMC, Commercial, and other stakeholders.
• Prepare and oversee regulatory submissions, briefing documents, and communications with regulatory agencies.
• Advise executive leadership on regulatory risks, opportunities, and evolving global regulatory requirements.
• Monitor changes in the regulatory landscape and incorporate new guidance into development strategies.
• Drive project planning, prioritize regulatory activities, and ensure key milestones are achieved on schedule.
• Mentor and develop members of the Regulatory Affairs team.

Qualifications

Education & Experience

• Bachelor's degree in Life Sciences with 10+ years of Regulatory Affairs experience in the U.S. pharmaceutical industry; or
• Master's degree with 8+ years of Regulatory Affairs experience; or
• Doctoral degree (PharmD, PhD, MD, etc.) with 6+ years of Regulatory Affairs experience.

Previous leadership or people management experience is preferred.

Required Skills & Experience

• Extensive experience developing regulatory strategies across the drug development lifecycle, from early clinical development through commercialization.
• Strong knowledge of FDA regulations and experience leading regulatory agency interactions and meetings.
• Experience preparing and managing regulatory submissions (e.g., INDs, NDAs, BLAs) and supporting global regulatory strategies.
• Experience supporting small molecules or biologics programs.
• Thorough understanding of clinical development, nonclinical requirements, safety reporting, labeling, and pharmaceutical regulations.
• Experience collaborating with cross-functional teams to drive regulatory strategy and product development.
• Knowledge of promotional material review, FDA OPDP requirements, and post-approval labeling management.