Senior Director, Head of Early Development Regulatory Affairs

Revolution Medicines•Redwood City, CA

8d•Hybrid

About The Position

The Senior Director, Head of Early Development Regulatory Affairs will lead global regulatory strategy for early-stage programs (pre-IND through Phase 2) across the portfolio. This leader will shape innovative and efficient regulatory pathways that enable rapid, science-driven development while positioning assets for long-term success. In addition to strategic leadership, this role will build and scale fit-for-purpose regulatory processes, frameworks, and capabilities to support portfolio growth. The position reports to the Head of Regulatory Sciences and serves as a key member of the Regulatory leadership team.

Requirements

8 years of regulatory experience in biotech or pharmaceutical industry required.
Significant experience leading early development programs (IND-enabling through Phase 2).
Demonstrated success leading global health authority interactions.
Experience building or scaling regulatory processes in a growing organization.
Ability to influence and partner with senior stakeholders.

Nice To Haves

10-12 years of regulatory experience in Biotech/Pharma industry is preferred.
Experience advising or leading regulatory strategy for basket, umbrella, and platform clinical trials preferred.
Advanced scientific or clinical degree preferred.
Demonstrated experience with dose optimization strategies in oncology (Project Optimus) preferred.

Responsibilities

Lead global regulatory strategy from candidate selection through end-of-Phase 2.
Shape early clinical development strategy by providing regulatory leadership on dose-finding approaches and indication selection that enable accelerated and differentiated development pathways and position asset for global registration and Health Authority Engagement.
Oversee strategy and cross functional alignment for global regulatory interactions and briefing documents (Pre-IND, IND, Scientific Advice, Type B/C meetings, PRIME, Sakigake, etc.).
Translate agency feedback into clear strategic direction, risk identification and risk mitigation plans.
Design and implement fit-for-purpose early development regulatory processes.
Establish clear governance, decision-making frameworks (e.g., RACI), and documentation standards.
Drive operational excellence in early regulatory planning, submission readiness, and execution.
Identify opportunities to streamline workflows and reduce bottlenecks as the organization grows.
Serve as regulatory representative in early development governance forums.
Advise senior leadership on regulatory risk, timelines, and probability of success.
Support business development diligence and integration activities.
Develop and mentor regulatory leaders in early development.
Build succession depth and technical capability within the function.
Foster a culture of strategic thinking, accountability, and collaboration.