Associate, Regulatory Affairs

Summit Therapeutics Inc. is a biopharmaceutical oncology company focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs. Our core values include integrity, passion for excellence, purposeful urgency, collaboration, and commitment to people. Summit is currently conducting multiple global Phase 3 clinical studies in non-small cell lung cancer (NSCLC) and colorectal cancer (CRC), including HARMONi, HARMONi-3, HARMONi-7, and HARMONi-GI3.

About the role

The Associate of Regulatory Affairs will support the day-to-day regulatory activities of assigned projects, including preparation and compilation of submissions for regulatory agencies, coordination of regulatory submission processes, and maintenance of submission timelines and archives.

Responsibilities

• Provide support for molecule and study-level regulatory activities, including clinical trial application (CTA) and IND submissions, review and approval of investigator document packages, and management of other regulatory aspects of studies under the direction of the Regulatory Affairs Lead.
• Prepare and coordinate routine and lifecycle submissions and related activities under the guidance of the RA Lead.
• Support development of regulatory content for BLA, NDA, and/or ex-U.S. marketing applications.
• Prepare and communicate regulatory status, timelines, risks, and action items to the RA lead and cross-functional study team.
• Maintain trackers for health-authority requests, responses, commitments, and due dates; coordinate subject-matter expert input under RA lead supervision.
• Collaborate with Project Team representatives in planning regulatory documents, including Health Authority Meetings and responses to Health Authority queries.
• Coordinate the review, finalization, and approval workflows for regulatory submissions.
• Maintain accurate regulatory and ethics submission and approval trackers for assigned studies.
• Maintain regulatory archives in collaboration with Regulatory Operations.
• Support global regulatory submissions and strategic planning as applicable.
• Perform all other duties as assigned.

Requirements

• BA/BS degree in biological or health-related sciences required.
• Relevant (bio)pharmaceutical industry experience, including experience in regulatory affairs.
• Foundational understanding of the drug-development process and applicable regulatory concepts, including FDA regulations, ICH guidelines, and Good Clinical Practice; willingness to develop knowledge of ex-U.S. requirements.
• Proficient in written, oral, and interpersonal communications in English.
• Ability to work in close collaboration with cross-functional colleagues.
• Strong attention to detail and ability to organize, prioritize, and complete assigned work within established timelines.
• Experience interacting with CROs in the management of ex-US CTAs towards clinical trial activations preferred, as well as ex-US Health Authority interactions and meetings.
• Proficient user of standard MS Office suite (e.g., Word, Excel); experience using electronic document management systems and document review tools desirable.
• Clear and concise oral and written communication skills.
• Excellent organizational skills.
• Critical thinking, problem-solving, and ability to complete assigned work with appropriate guidance, escalating questions or risks promptly.
• Ability to work effectively in a dynamic, deadline-driven, and collaborative environment.

Pay

$97,000 - $114,000 USD. Actual compensation packages are based on several factors unique to each candidate, including skill set, depth of experience, certifications, and specific work location.