Associate Director, Regulatory Affairs

🕒 September 8

🇺🇸 United States – Remote

💵 $168k - $198k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

👻 Ghost score 30%

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Summit Therapeutics, Inc.

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2003

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

Healthcare • Biotechnology • Pharmaceuticals

Summit Therapeutics, Inc. is a biopharmaceutical oncology company focused on the discovery, development, and commercialization of innovative medicinal therapies aimed at improving quality of life for oncology patients. The company is particularly committed to addressing serious unmet medical needs through its lead investigational therapy, ivonescimab, a novel bispecific antibody designed to target both PD-1 and VEGF. Summit’s initiatives include ongoing Phase III clinical trials to evaluate ivonescimab's effectiveness in treating non-small cell lung cancer, highlighting their dedication to patient-centered care and technological advancement in the field of oncology.

📋 Description

• Provide scientific and biological regulatory guidance to project teams and key sub-teams at the clinical study level • Assess, develop, and implement competitive global regulatory strategies for ivonescimab • Independently manage regulatory activities at the molecule and clinical study levels, including CTA and IND submissions • Review and approve investigator document packages and associated FDA submissions • Apply scientific, biological, technical, and regulatory knowledge throughout the clinical development process • Present and communicate study-level regulatory activities to project teams • Coordinate written responses to agency queries, track regulatory commitments, and communicate progress • Own scientific and regulatory content and strategy for BLA and MAA filings • Track regulatory timelines, maintain regulatory dossiers, and manage regulatory queries • Serve as Summit’s liaison with the FDA for health authority meetings • Lead cross-functional preparation of meeting requests, meeting packages, agency responses, defense preparation sessions, and health authority meetings • Ensure regulatory submissions are scientifically and regulatorily consistent, complete, adequate, and compliant with submission standards • Apply therapeutic-area knowledge, including lung cancer, to regulatory oversight and clinical development • Oversee labelling meetings as required • Direct and coordinate review, finalization, and sign-off of regulatory submissions • Maintain records of regulatory and ethics submissions and approvals across clinical studies • Manage document archiving processes • Provide cross-coverage and train new employees on regulatory processes and submission procedures • Support departmental initiatives, scientific and regulatory training, and related activities • Perform other duties as assigned

🎯 Requirements

• BA/BS degree in Biotechnology, Biological Sciences, or related field required • Minimum of 5+ years of experience in regulatory affairs • Relevant biopharmaceutical industry experience • Knowledge of US FDA and international pharmaceutical guidance, regulations, drug development process, and industry-standard practices • Experience working in a complex and matrix environment with multiple stakeholders • Experience interfacing with government regulatory agencies and Health Authorities • Strong written and oral communications in English • Strong negotiation skills and ability to build consensus cross-functionally and within regulatory affairs • Strong clinical foundation and understanding of the disease landscape • Experience interfacing with regulatory health authorities • Careful attention to detail; ability to organize, prioritize, and delegate assigned projects • Proficient user of standard MS Office suite, including Word and Excel • Experience using electronic document management systems and document review tools is desirable • Experience interacting with CROs in management of ex-US CTAs and ex-US Health Authority interactions is preferred • Knowledge of Chinese is desirable • Graduate-level degree (MS, PhD, or PharmD) is a plus

🏖️ Benefits

• Bonus, stock, benefits and/or other applicable variable compensation may be included in the total compensation package • Equal Opportunity Employer

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