Description

The VP/SVP, Head of Regulatory Affairs will provide strategic and operational leadership for the Company’s global regulatory function and serve as a key member of the leadership team. This individual will be responsible for developing and executing global regulatory strategies across the Company’s oncology portfolio, from early development through registration and lifecycle management. The role will lead interactions with global health authorities, provide regulatory guidance to executive leadership and cross-functional development teams, and build and lead a high-performing Regulatory Affairs and Medical Writing organization.

Key Responsibilities

Global Regulatory Strategy: Develop and execute integrated global regulatory strategies across the Company’s oncology portfolio, from early development and IND-enabling activities through clinical development, registration, commercialization, and lifecycle management. Ensure regulatory strategies are aligned with corporate and product development objectives.
Clinical Development Strategy: Provide strategic regulatory guidance on clinical development plans, target product profiles, pivotal trial design, registration pathways, and global development sequencing. Partner closely with Clinical Development, Biostatistics, Clinical Operations, CMC, and other functions to optimize development and registration strategies.
Regulatory Submissions & Approvals: Lead and oversee the preparation, submission, and management of major regulatory applications, including INDs, BLAs, MAAs, and other global submissions. Drive regulatory strategy and execution toward timely approvals across key markets.
Health Authority Interactions: Serve as the senior regulatory representative and lead key interactions and negotiations with the FDA, EMA, and other global health authorities, including Pre-IND, End-of-Phase, Type B/C, pre-BLA and other critical regulatory meetings.
Regulatory Risk Management & Intelligence: Proactively identify regulatory risks, opportunities, and evolving requirements; develop mitigation strategies and leverage regulatory intelligence and competitive insights to inform development and business decisions.
Medical Writing Oversight: Provide strategic oversight of Medical Writing activities to ensure high-quality, scientifically rigorous, and timely regulatory and clinical documentation supporting global development and submissions.
Organization & Team Leadership: Build, develop, and lead a high-performing Regulatory Affairs and Medical Writing organization. Establish scalable processes, capabilities, and infrastructure to support the Company’s growing global portfolio while mentoring and developing team members.

Qualifications

Head of Regulatory Affairs & Medical Writing (VP/SVP)

Description

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