Senior Director, Head of Early Development Regulatory Affairs

Primary 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.
• 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.

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.