Senior Director Regulatory Strategy

Overview

An innovative, clinical-stage biotechnology company is seeking a Senior Director of Regulatory Affairs to lead global oncology regulatory strategy. This individual will play a highly visible, hands-on role partnering cross-functionally to advance early-stage oncology programs through development and key regulatory milestones.

Key Responsibilities

• Lead and execute global regulatory strategies for early-stage oncology assets, with a strong emphasis on Phase 1 development.

• Drive creative, differentiated regulatory approaches—moving beyond traditional precedent to support novel scientific and clinical strategies.

• Serve as the primary liaison with health authorities (e.g., FDA and ex-U.S. agencies), leading interactions, meetings, and negotiations.

• Own the preparation of key regulatory deliverables, including briefing documents, submissions, and agency packages (INDs, CTAs, etc.).

• Provide strategic guidance to cross-functional stakeholders (clinical, CMC, safety, and commercial) to align regulatory direction with program goals.

• Identify regulatory risks early and develop mitigation strategies that enable efficient program advancement.

• Ensure high-quality, submission-ready documentation that meets global regulatory standards.

• Contribute to inspection readiness and support regulatory compliance activities.

• Partner in business development efforts, providing regulatory insight on potential opportunities.

• Help build and scale regulatory processes, infrastructure, and ways of working in a growing organization.

• Manage external vendors and support budget-conscious execution of regulatory activities.

• Mentor and develop team members while fostering a collaborative and high-performing culture.

Ideal Candidate Profile

• Extensive experience in Regulatory Affairs within biotechnology or pharmaceuticals, with a strong focus in oncology.

• Deep expertise in early-stage (Phase 1) oncology development—this is critical.

• Proven ability to design and articulate innovative regulatory strategies, particularly in complex or novel therapeutic areas.

• Demonstrated success leading health authority interactions and influencing outcomes.

• Hands-on experience preparing briefing books and regulatory submissions from the ground up.

• Comfortable operating in lean environments—balancing strategic thinking with execution while working within budget constraints.

• Strong track record of working cross-functionally and driving alignment across diverse teams.

• Excellent communication skills, with the ability to clearly present complex regulatory strategies to internal and external stakeholders.

• Prior leadership experience with a focus on team development and organizational growth is preferred.

What Sets This Role Apart

• Significant ownership over regulatory strategy at an early stage of development

• Opportunity to shape novel oncology programs with creative, non-traditional approaches

• High-impact role in a growing organization where process-building and agility are key

• Exposure to executive leadership and meaningful influence on pipeline direction