Associate, Regulatory Affairs

Summit Therapeutics, Inc.; Palo Alto (CA); On-site; USD 97,000 - 114,000; Full time

Job summary

Summit Therapeutics Inc. is seeking an Associate of Regulatory Affairs to support day-to-day regulatory activities for assigned projects, including submissions to regulatory agencies and maintenance of submission timelines.

The role involves coordinating with cross-functional teams, preparing routine and lifecycle submissions, and assisting with regulatory content for BLA/NDA and ex-US applications. Ideal candidates have a BA/BS in biological or health sciences, familiarity with FDA/ICH

Qualifications

• Regulatory affairs experience in pharma/biotech.
• Foundational understanding of drug development, FDA regulations, ICH, and Good Clinical Practice; willingness to learn ex-US requirements.
• Strong written and spoken English, excellent communication skills.
• Ability to collaborate with cross-functional teams and manage timelines with attention to detail.

Responsibilities

• Support molecule- and study-level regulatory activities including CTA/IND submissions.
• Prepare and coordinate routine and lifecycle submissions under RA Lead guidance.
• Assist in developing regulatory content for BLA/NDA and ex-US applications.
• Communicate regulatory status, timelines, risks, and actions to the RA Lead and study team.
• Maintain trackers for health-authority requests and responses; coordinate input from SMEs.
• Collaborate on regulatory documents planning including Health Authority Meetings.
• Coordinate review and approval workflows for regulatory submissions.
• Maintain regulatory archives and support global submissions and strategic planning.
• All other duties as assigned

Education

BA/BS degree in biological or health related sciences

Tools

MS Office

Electronic document management systems

Job description

About Summit

Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs. At Summit, we believe in building a team of world class professionals who are passionate about this mission, and it is our people who drive this mission to reality. Summit’s core values include integrity, passion for excellence, purposeful urgency, collaboration, and our commitment to people. Our employees are truly the heart and soul of our culture, and they are invaluable in shaping our journey toward excellence.

About Summit

Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs. At Summit, we believe in building a team of world class professionals who are passionate about this mission, and it is our people who drive this mission to reality. Summit’s core values include integrity, passion for excellence, purposeful urgency, collaboration, and our commitment to people. Our employees are truly the heart and soul of our culture, and they are invaluable in shaping our journey toward excellence.

Non-small Cell Lung Cancer (NSCLC)

• HARMONi: Phase 3 clinical study which was intended to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a 3rd generation EGFR TKI.
• HARMONi-3: Phase 3 clinical study which is intended to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC.
• HARMONi-7: Phase 3 clinical study which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC.

Colorectal Cancer (CRC)

• HARMONi-GI3: Phase 3 clinical study intended to evaluate ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy.

Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than China’s National Medical Products Administration (NMPA). Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland.

Overview Of Role

The Associate of Regulatory Affairs will support the day-to-day regulatory activities of assigned projects. These assigned projects include support of preparation and compilation of submissions for regulatory agencies, clinical studies, coordination of regulatory submission processes and maintenance of submission timelines, regulatory tracking tools, archives, and infrastructure, as assigned.

Role And Responsibilities

• Provide support of molecule and study-level regulatory activities, including clinical trial application (CTA) and IND submissions, review and approval of investigator document packages and associated FDA submissions, and manage other regulatory aspects of the studies as necessary under 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-US 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 the Project Team representatives in the planning of 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, where applicable, 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
• All other duties as assigned

Experience, Education And Specialized Knowledge And Skills

• BA/BS degree in the 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, meetings etc.
• 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, ability to complete assigned work with appropriate guidance and elevate questions or risks promptly.
• Ability to work effectively in a dynamic, deadline-driven, and collaborative environment.

This is the pay for this position. Pay Transparency: $97,000 - $114,000 USD. Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation.

Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summit’s Talent Acquisition team at [e-mail] to obtain prior written authorization before referring any candidates to Summit.

Summit Therapeutics Inc. is an Equal Opportunity Employer and takes pride in creating and maintaining diverse environment. We do not discriminate in recruitment, hiring, training or promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.