Associate Director, Regulatory Affairs

🕒 4 days ago

🇺🇸 United States – Remote

💵 $168k - $198k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

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Summit Therapeutics, Inc.

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 2003

🏥 Healthcare

💼 Consulting

📣 Marketing

🔥 Funding within the last year

💰 $500M Post-IPO Equity - Summit Therapeutics on 2025-10

Healthcare • Consulting • Marketing

Summit Therapeutics, Inc. is a biopharmaceutical oncology company focused on the discovery, development, and commercialization of novel medicinal therapies to improve quality and duration of life for patients with serious unmet medical needs. The company is advancing ivonescimab (SMT112), a novel bispecific antibody targeting PD-1 and VEGF, through multiple Phase 3 clinical trials for non-small cell lung cancer and other solid tumors under license from Akeso. Summit emphasizes clinical development, regulatory filing strategies, and potential commercialization in its licensed territories while promoting patient- and caregiver-friendly treatment options.

📋 Description

• Provide regulatory guidance to project teams and key study-level sub-teams • Assess, develop, and implement competitive global regulatory strategies for ivonescimab • Identify regulatory risks, mitigation steps, and proposed strategies • Own molecule- and study-level regulatory activities, including CTA and IND submissions • Review and approve investigator document packages and associated FDA submissions • Manage regulatory submission processes, timelines, tracking tools, archives, and infrastructure • Present regulatory activities and interpret regulatory requirements for study teams • Manage regulatory agency queries and commitments, collaborating with subject matter experts on written responses • Own regulatory content and strategy for BLA or MAA filings • Track timelines, regulatory dossiers, and regulatory queries • Serve as FDA Health Authority liaison for meetings • Plan regulatory meeting requests and packages, coordinate cross-functional preparation, and lead responses and meetings • Ensure regulatory submissions are consistent, complete, and compliant with standards • Apply expertise in lung cancer and other relevant indications • Oversee labelling meetings • Lead review, finalization, and sign-off processes for regulatory submissions • Track regulatory and ethics submissions and approvals across studies • Manage document archive processes • Provide cross-coverage and train new employees as needed • Support department initiatives and training • Perform other assigned duties

🎯 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 work under pressure and proactively • Strong clinical foundation and understanding of the disease landscape • Attention to detail and ability to organize, prioritize, and delegate assigned projects • Global regulatory experience required • Knowledge of Chinese is desirable • Experience interacting with CROs in managing ex-US CTAs and ex-US Health Authority interactions preferred • Proficiency in MS Office suite, electronic document management systems, and document review tools desirable

🏖️ Benefits

• Potential bonus • Stock • Benefits and/or other applicable variable compensation • Equal Opportunity Employer commitment and nondiscrimination in recruitment, hiring, training, and promotion