Senior Director, Regulatory Affairs

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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

• Develop and implement global strategies to secure IND/CTA approvals for studies • Provide regulatory leadership for planning and execution of global marketing applications (BLA/MAA) for oncology products • Lead global regulatory strategies for assigned products and indications through all phases of development • Support Regulatory Affairs for development collaborations and partnerships and serve as the primary Summit regulatory contact for partner IND/CTA study requirements • Expand therapeutic-area knowledge and ensure strategic messaging and content of global regulatory dossiers • Develop tumor landscape assessments to inform evolving development strategy • Advise management and cross-functional team members on relevant laws, regulations, guidelines, and standards • Lead Labeling Regulatory Teams for assigned products or indications as needed • Ensure corporate goals are met for assigned projects • Coach and mentor other regulatory team members • Potentially manage direct reports and contribute to performance management for other Regulatory Affairs team members • Participate in and take leadership roles in professional associations, industry, and trade groups as appropriate • Follow budget allocations

🎯 Requirements

• Bachelor's degree in life sciences (pharmacy, biology, chemistry, pharmacology) or a related subject; Master's or Doctorate preferred • Minimum of 10+ years' experience in pharmaceutical regulatory activities • Experience as lead regulatory product strategist in two or more major regions in addition to the US, such as the EU, Japan, or China • Experience and direct involvement with marketing/license applications, such as BLA, NDA, and MAA • Drug development experience in the US and EU • Minimum of 5+ years of proven experience in a strategic leadership role • Strong project management skills • Experience working in a cross-functional environment with multiple stakeholders and influencing cross-functional teams • Experience interfacing with major government regulatory authorities • Strong communication and proactive negotiation skills • Ability to communicate effectively and articulate complex ideas in an easily understandable way • Ability to work successfully in a fast-paced, demanding, and collaborative environment • Willingness to travel up to approximately 5%

🏖️ Benefits

• Bonus, stock, benefits and/or other applicable variable compensation may be included in the total compensation package • Approximately 5% travel