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Job description
Senior Director / Executive Director, Regulatory Affairs Strategy
Position Overview
We are seeking an experienced and highly strategic Senior Director or Executive Director of Regulatory Affairs Strategy to lead global regulatory activities for our oncology development programs. As the company advances its lead program into Phase III development and prepares for potential commercialization, this individual will define and execute the regulatory strategy required to achieve approval and support a successful product launch.
The ideal candidate will have significant experience leading late-stage oncology programs, including Phase III development and the preparation, submission, and approval of an NDA or BLA. This individual will serve as a senior regulatory leader and partner closely with Clinical Development, Clinical Operations, Biometrics, Medical Affairs, CMC, Commercial, and executive leadership.
The position may be filled at the Senior Director or Executive Director level based on the selected candidate’s experience and qualifications.
Key Responsibilities
Develop and execute global regulatory strategies for late-stage oncology programs, with an emphasis on Phase III development, registration, and commercialization
Lead regulatory planning and execution for NDA or BLA preparation, submission, review, and approval
Serve as the primary regulatory strategist for assigned programs, providing clear and actionable guidance to development teams and senior leadership
Lead interactions with the FDA and other global health authorities, including Type B and Type C meetings, end-of-Phase II meetings, pre-NDA or pre-BLA meetings, and advisory committee preparation
Translate regulatory requirements and health authority feedback into integrated development plans, submission strategies, and program-level recommendations
Provide regulatory leadership for Phase III protocol development, statistical analysis plans, clinical study reports, and other registration-enabling documents
Partner with Clinical Development and Biometrics to ensure pivotal trial designs, endpoints, patient populations, and statistical approaches support the intended regulatory pathway and target product profile
Lead the preparation of briefing documents, meeting requests, responses to health authority questions, and regulatory correspondence
Oversee the development and delivery of high-quality regulatory submissions, including IND amendments, annual reports, expedited program designation requests, NDA or BLA modules, and post-approval commitments
Collaborate with CMC Regulatory, Quality, Safety, Medical Writing, and Clinical Operations to ensure alignment across all components of the marketing application
Partner with Medical Affairs, Commercial, and Market Access to develop regulatory strategies supporting product positioning, labeling, launch readiness, and commercialization
Lead the development and negotiation of product labeling, including prescribing information and other region-specific labeling components
Identify regulatory risks, dependencies, and opportunities while developing practical mitigation strategies that protect program timelines
Monitor evolving oncology regulatory requirements, precedents, and competitive developments that may affect development or commercialization strategy
Support regulatory due diligence, business development activities, and portfolio planning as needed
Represent Regulatory Affairs on cross-functional governance teams and communicate key regulatory considerations to executive leadership and the Board, as appropriate
Mentor and develop regulatory team members while helping build scalable regulatory capabilities for a growing organization
Required Qualifications
Bachelor’s degree in life sciences, pharmacy, medicine, or a related discipline; an advanced degree is preferred
Approximately 12 or more years of progressive regulatory affairs experience within the biotechnology or pharmaceutical industry
Significant experience supporting the development of oncology therapeutics
Demonstrated leadership of at least one late-stage or Phase III development program
Direct experience leading, or playing a major strategic leadership role in, an NDA or BLA submission
Experience supporting a product through regulatory approval, launch preparation, or commercialization
Strong knowledge of FDA regulations, ICH guidelines, and global drug development requirements
Proven experience leading interactions with the FDA and other global health authorities
Deep understanding of pivotal trial strategy, registration pathways, benefit-risk assessment, labeling, and submission planning
Ability to provide strategic direction while remaining closely involved in the execution of critical regulatory deliverables
Strong cross-functional leadership skills and the ability to influence decisions without direct authority
Excellent written, verbal, presentation, and executive communication skills
Ability to operate effectively in a fast-paced and evolving biotechnology environment with competing priorities and aggressive development timelines
Preferred Qualifications
Experience with novel oncology therapeutics, including biologics, targeted therapies, immuno-oncology agents, or other innovative treatment modalities
Experience with expedited development programs, including Breakthrough Therapy, Fast Track, Priority Review, Accelerated Approval, or Real-Time Oncology Review
Experience leading pre-NDA or pre-BLA meetings and managing health authority review activities through approval
Global regulatory experience supporting submissions in the United States, Europe, and other major markets
Experience developing regulatory strategies for companion diagnostics, combination therapies, or biomarker-defined patient populations
Previous experience within a small or mid-sized biotechnology company preparing for its first commercial launch
Leadership Profile
The successful candidate will be a forward-looking regulatory strategist who can balance scientific rigor, regulatory requirements, and business objectives. This individual must be comfortable operating at both the strategic and executional levels and will bring sound judgment, urgency, and a collaborative leadership style to a company entering a transformational stage of development.
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Worksite address
san francisco, CA, 94199, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.