Executive Director, Regulatory Strategy

About the Role

The Executive Director, Regulatory Affairs oversees all regulatory activities for new development programs, from pre-IND through BLA/NDA and post-approval. This role is responsible for developing and implementing global regulatory strategies across clinical, non-clinical, and CMC disciplines, ensuring timely and scientifically valid submissions, and maintaining strong relationships with regulatory agencies.

Responsibilities

• Oversight and management of Regulatory Program Leaders and their staff.
• Develop and implement regulatory strategies to maximize chances of successful registration.
• Maintain a good working relationship with the FDA and other Health Authorities.
• Ensure submitted documents are complete, well-organized, high-quality, and compliant with regulatory requirements.
• Address regulatory agency requirements for additional clinical indications and new dosage forms.
• Manage clinical development program planning to anticipate regulatory changes.
• Oversee interactions with Health Authorities to ensure efficient review and approval of submissions.
• Prepare and submit INDs, NDAs, BLAs, reports, and correspondence to regulatory agencies.
• Plan and implement meetings with regulatory agencies.
• Coordinate completion of adverse reaction and safety reports within regulatory timelines.
• Monitor regulatory, scientific, and legal issues and advise management on significant events.
• Critically review nonclinical, chemistry, manufacturing, and clinical trial documentation for compliance.
• Provide regulatory strategic guidance on documents and submission plans.
• Optimize and implement processes and procedures, including developing internal work instructions and SOPs.
• Liaise internally with functional departments and externally with vendors, licensors, and collaborators.
• Develop staff and ensure documentation of individual development plans.

Qualifications

• BS/BA degree in related discipline and a minimum of 18 years of related experience.
• MS/MA degree in related discipline and a minimum of 16 years of related experience.
• PhD in related discipline and a minimum of 15 years of related experience.
• Equivalent combination of education and experience.
• May require certification in assigned area.

Experience

• Minimum 18 years of pharmaceutical industry and/or regulatory agency experience.
• Minimum nine years of regulatory experience in a position of substantial responsibility.
• Prior experience working with relevant FDA review divisions.
• Experience in oncology drug development required.

Skills

• Extensive experience in relevant industry/profession.
• Ability to develop technical and business solutions to complex problems.
• Comprehensive understanding of current industry approaches.
• Strong analytical and business communication skills.
• Demonstrated knowledge of US and international regulatory requirements.
• Leadership skills in problem-solving and strategic thinking.

Pay

The base pay range for this position is $268,500 - $380,000 annually, adjusted based on geographic region and other factors.

Benefits

• Comprehensive employee benefits package, including 401k with generous company contributions.
• Group medical, dental, and vision coverage.
• Life and disability insurance.
• Flexible spending accounts.
• Discretionary annual bonus program.
• Opportunity to purchase company stock and receive long-term incentives.
• 15 accrued vacation days in the first year, 17 paid holidays, and up to 10 sick days.

Working Conditions

Primarily indoor work in a modern, collaborative office environment with necessary equipment provided.