Associate Director of Regulatory Affairs

Summit Therapeutics Inc. is a biopharmaceutical oncology company focused on improving quality of life, increasing potential duration of life, and addressing serious unmet medical needs. The company’s core values include integrity, passion for excellence, purposeful urgency, collaboration, and commitment to people.

The Associate Director of Regulatory Affairs will support the day-to-day regulatory activities of assigned projects with an in-depth knowledge and understanding of the regulatory environment. Global regulatory experience is required. These projects include support for preparation and compilation of submissions for regulatory agencies, tasking clinical studies, managing regulatory submission processes and timelines, regulatory tracking tools, archives, and infrastructure.

Role and Responsibilities:

• Provides regulatory guidance on project teams and key sub-teams at the study level.
• Assesses, develops, and implements competitive global regulatory strategies for ivonescimab, identifying potential risks and mitigation steps with proposed strategies.
• Owns regulatory activities at the molecule and study-level, including clinical trial application (CTA) and IND submissions, review and approval of investigator document packages and associated FDA submissions, and manages other day-to-day regulatory activities of the studies independently.
• Broadly applies regulatory/technical knowledge of government regulations and skills.
• Presents and informs study teams of regulatory activities at study team meetings, providing interpretation and application of regulatory requirements.
• Manages and tracks queries and commitments with regulatory agencies, collaborates with subject matter experts to provide written responses to queries, and provides periodic status updates regarding unfulfilled conditions and/or commitments.
• Key contributor and owns the regulatory content and strategy for BLA or MAA filings.
• Tracks timelines, is responsible for the regulatory dossier, and manages regulatory queries.
• Health authority (HA) meetings: Serves as the health authority (HA) liaison with the FDA for meetings. Prepares and leads project teams in planning regulatory meeting requests and meeting packages, coordinates and leads cross-functional regulatory defense preparation meetings, responds to health authority queries, and attends health authority meetings.
• Ensures consistency, completeness, and adherence to standards for all regulatory submissions in accordance with regulatory requirements.
• Demonstrates expertise and knowledge of lung cancer and other indications as needed.
• Oversees labeling meetings as required.
• Leads processes by which regulatory submissions are reviewed, finalized, and signed off.
• Manages the track record of regulatory/ethics submissions and approvals across all studies.
• Manages document archive processes.
• Provides cross-coverage when other members are on leave and trains new employees as needed.
• Supports non-program-specific projects, such as department initiatives and training.
• All other duties as assigned.