Executive Director/Senior Director Regulatory Affairs

Precision Point; San Francisco (CA); On-site; USD 230,000 - 320,000; Full time

Job summary

Precision Point, a biotechnology company in San Francisco, seeks a Senior Director/Executive Director, Regulatory Affairs Strategy to lead global regulatory activities for oncology programs advancing to Phase III and potential commercialization.

The successful candidate will partner with Clinical Development, Biometrics, Medical Affairs, and executive leadership to define strategies, manage NDA/BLA submissions, and guide interactions with FDA and other authorities, while mentoring the regulatory

Qualifications

• 12+ years of progressive regulatory affairs experience in biotech/pharma
• Experience leading oncology therapeutics development
• Direct NDA/BLA submission experience
• Strong knowledge of FDA regulations and global drug development requirements
• Experience interacting with FDA and global health authorities

Responsibilities

• Develop global regulatory strategies for late-stage oncology programs (Phase III)
• Lead NDA/BLA preparation, submission, and approval
• Serve as primary regulatory strategist for assigned programs
• Lead FDA and health authority meetings and provide guidance to teams
• Translate health authority feedback into integrated development plans
• Oversee regulatory submissions and post-approval commitments
• Collaborate with CMC, Quality, Safety, Medical Writing, and Clinical Operations
• Partner with Medical Affairs, Commercial, and Market Access on strategy and launch readiness
• Mentor regulatory team and build scalable capabilities

Skills

Strategic leadership

Regulatory strategy

Cross-functional collaboration

FDA communications

Education

Bachelor's degree in life sciences/related field

Advanced degree preferred

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.