Senior Director, Head of Early Development Regulatory Affairs

The Opportunity:

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.

Primary Responsibilities:

Early Development Strategy

• 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.

• Build Scalable Regulatory Infrastructure.

• 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.

Cross-Functional & Portfolio Leadership

• 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.

Organizational & Talent Development

• 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.

Required Skills, Experience and Education:

• 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.

Preferred Skills:

• 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. 

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