Associate Director, Regulatory Affairs

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. Summit’s team is inspired to touch and help change lives through Summit’s clinical studies in the field of oncology. Summit has multiple global Phase 3 clinical studies, including: 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. 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 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 assigned projects include support of preparation and compilation of submissions for regulatory agencies, tasked clinical studies, management of regulatory submission processes and timelines, regulatory tracking tools, archives, and infrastructure, as assigned. Role and Responsibilities: Pr ovides regulatory guidance on project teams and key sub-teams at study level Assess, develop, and implement competitive global regulatory strategies for ivonescimab, and identify potential risks and mitigation steps with proposed strategies Own regulatory activities at molecule and study-level, including clinical trial application (CTA) and IND submissions, review and approval of investigator document packages and associated FDA submissions, and manage other day-to-day regulatory activities of the studies as necessary and independently Broadly applies regulatory/technical knowledge of government regulations and skills Present and inform study team of regulatory activities at study team meetings and provide interpretation and application of regulatory requirements Manage and track queries and commitments with regulatory agencies, collaborate with subject matter experts to provide written responses to queries, provide periodic status updates regarding unfulfilled conditions and/or commitments Key contributor and owns the regulatory content and strategy for BLA or MAA filings Tracks the timelines, responsible for the regulatory dossier and manages the regulatory queries Health authority (HA) meetings: Serves as health authority (HA) liaison with FDA for meetings. Prepares and leads project team in the planning of regulatory meeting request and meeting package, coordinates and leads cross-functional regulatory defence preparation meetings, responses to health authority queries, and health authority meetings. Ensure consistency, completeness, and adherence to standards for all regulatory submissions in accordance with regulatory requirements Demonstrate expertise and knowledge of lung cancer and other indications as needed Oversee labelling meetings as required Lead processes by which regulatory submissions are reviewed, finalized, and signed-off Manage the track record of regulatory/ethics submissions and approvals across all studies Provide cross-coverage when other members are on leave, and train new employees as needed Support non-program specific projects, such as department initiatives, training, etc. All other duties as assigned Experience, Education and Specialized Knowledge and Skills: BA/BS degree in Biotechnology, Biological Sciences, or related field required; graduate-level degree, e.g., MS, PhD, or PharmD a plus Relevant (bio) pharmaceutical industry experience, including a minimum of 5+ years of experience in regulatory affairs Knowledgeable of US FDA and international pharmaceutical guidance, regulations, drug development process, and industry-standard practices Experience working in a complex and matrix environment, and with multiple stakeholders. Experience interfacing with government regulatory agencies. Experience working with Health Authority Strong written, oral communications in English. Strong negotiation skills, including ability to work under pressure and proactively, and build consensus cross-functionally and within regulatory affairs Strong clinical foundation and understanding of disease landscape under consideration. Experience in interfacing with regulatory health authorities Knowledge of Chinese is desirable Careful attention to detail; ability to organize, prioritize, and delegate assigned projects Experience interacting with CROs in the management of ex-US CTAs towards clinical trial activations preferred as well as ex-US HA 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 This is the pay for this position Pay Transparency $168,000 - $198,000 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 View email address on click.appcast.io 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. #J-18808-Ljbffr