Senior Director, Regulatory Affairs

Summit Therapeutics, Inc.

Senior Director leading global oncology regulatory strategies and IND/CTA approvals at Summit Therapeutics, a biopharmaceutical oncology company. Guiding BLA/MAA submissions, cross-functional teams, partnerships, and regulatory personnel.

Posted 8/18/2026full-timeRemote • 🇺🇸 United StatesSenior💰 $203,000 - $253,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive expertise in regulatory strategy development and execution for oncology products, with a strong focus on IND/CTA approvals and marketing applications. Proven ability to lead cross-functional teams and mentor regulatory professionals while ensuring compliance with global regulations.

Highest-signal resume keywords

Regulatory Strategy DevelopmentIND/CTA ApprovalsBLA/MAA ApplicationsCross-Functional Team LeadershipProject Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory AffairsDrug DevelopmentMarketing ApplicationsOncology ProductsTumor Landscape AssessmentsRegulatory DossiersPerformance ManagementStrategic LeadershipGovernment Regulatory AuthoritiesLife Sciences Degree

Soft Skills

Strong CommunicationProactive NegotiationCollaborationMentoringInfluencing Stakeholders

Industry Keywords

Pharmaceutical Regulatory ActivitiesEU RegulationsUS RegulationsCross-Functional EnvironmentProfessional Associations

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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