Head of Regulatory Affairs & Medical Writing (VP/Sr.VP)

Systimmune • Princeton, NJ, US • published 2026-09-22 23:43:00.304006

Description

Princeton, NJ Full Time Regulatory Affairs \& Medical Writing Executive 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 ...

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