About the Role
About the Company
Our client is a fast-growing oncology biotechnology company advancing a pipeline of novel therapies with the potential to transform patient outcomes. With multiple assets progressing through development, they’re expanding the leadership team to support global growth and upcoming regulatory milestones.
Position Overview
The Global Head of Regulatory Affairs will serve as the company’s senior regulatory leader, shaping and driving global regulatory strategy across a dynamic oncology portfolio. This role will oversee all regulatory activities, guide cross-functional teams through major submissions and health authority interactions, and build a high-performing regulatory organization that can scale with the company’s ambitions.
Key Responsibilities
Develop and lead global regulatory strategy for all programs, ensuring alignment with clinical, CMC, and commercial plans.
Serve as the primary point of contact with FDA, EMA, and other global health authorities; lead key meetings and communications.
Oversee preparation, quality, and timely submission of INDs/CTAs, BLAs/MAAs, expedited program applications, amendments, and other regulatory filings.
Anticipate regulatory risks and opportunities, advising senior leadership on strategic implications and pathways for accelerated development.
Partner closely with R&D, Clinical Development, Medical Affairs, Quality, CMC, and Commercial to ensure consistent regulatory input across the organization.
Build, mentor, and scale a global regulatory affairs team; assess external resources and manage regulatory consultants as needed.
Monitor evolving regulatory guidelines, policy developments, and oncology-specific requirements to ensure ongoing compliance.
Support lifecycle management activities and contribute to long-term global launch planning.
Requirements
Advanced degree in a scientific discipline (PhD, PharmD, MD, or MS preferred).
Extensive regulatory experience within biotech/pharma, including senior leadership responsibilities and direct engagement with global health authorities.
Proven success leading regulatory strategy for oncology programs, ideally spanning early- and late-stage development.
Strong track record in authoring and overseeing major regulatory submissions (e.g., IND, BLA/MAA).
Experience leading regulatory interactions for accelerated pathways (Fast Track, Breakthrough, PRIME) highly valued.
Ability to thrive in a fast-moving, scaling environment and bring structure, foresight, and adaptability to complex development programs.
Exceptional communication, leadership, and cross-functional collaboration skills.
About the Company
Our client is a fast-growing oncology biotechnology company advancing a pipeline of novel therapies with the potential to transform patient outcomes. With multiple assets progressing through development, they're expanding the leadership team to support global growth and upcoming regulatory milestones.
