Summit Therapeutics, Inc. · 4 days ago
Executive Director, Regulatory Affairs - Global Regulatory Leader
United States
Full-time
Remote
Director/Executive
$238K/yr - $298K/yr
15+ years expSummit Therapeutics Inc. is a biopharmaceutical oncology company focused on improving quality of life and addressing unmet medical needs. The Executive Director of Regulatory Affairs - Global Regulatory Leader is responsible for developing global strategies to secure regulatory approvals and providing leadership for marketing applications in oncology.
BiotechnologyHealth CareMedical DeviceTherapeutics
Responsibilities
Act independently to lead global regulatory strategies for assigned products/indications through all phases of development to include regulatory approvals/product launches, and post-marketing efforts
Will represent Regulatory Affairs as relates to development collaborations and/or partnerships, to include leading due diligence as required supporting BD activities
For new indications assigned, will lead effort on behalf of regulatory cross-functionally with colleagues from clinical, biostatistics, commercial, medical affairs, clinical pharmacology, safety, and others. Expected to provide material (content) input into potential study synopses and corresponding global regulatory briefing documents
Continually expands TA knowledge and ensures strategic messaging and content of global regulatory dossiers, to include development of tumor landscape assessment to inform evolving development strategy
Advises management and cross-functional team members of the effect of current or proposed relevant laws, regulations, guidelines, and standards, etc
Key internal leader and driver of regulatory policy and strategy for assigned products
Lead regulatory team in the preparation and maintenance of risk assessment and mitigation strategy development for assigned products
Lead labeling strategy for given product(s)/indication(s), in support of initial license applications through post-marketing
Demonstrates excellent understanding of drug development and leadership behaviors consistent with the level
Accountable for ensuring that corporate goals are met with respect to assigned projects
Acts independently under direction of Vice President of Regulatory Affairs, with the Executive Director expected to represent regulatory with little to no oversight
Based on experience and scientific strengths, expands TA knowledge of TA; provides coaching and mentoring for other regulatory members and extra-departmental colleagues
Will have direct reports and contributes to the performance management for other RA team members
May advance the organization's goals by participating and taking leadership roles in professional associations, industry, and trade groups as appropriate
Follows budget allocations
All other duties as assigned
Qualification
Required
Bachelor's degree in life sciences (pharmacy, biology, chemistry, pharmacology) or related subject; Masters or Doctorate preferred
Minimum of 15+ years of experience in pharmaceutical/biotech regulatory activities, with experience as lead regulatory product strategist in two or more major regions in addition to the US, such as EU, Japan, or China
Expected to have significant experience with direct involvement/leadership as relates to marketing/license applications (e.g., BLA, NDA, MAA), and given late-stage nature of Summit's clinical development program(s), experience supporting regulatory approvals and required activities in support of product launch and post marketing efforts
Significant experience dealing with partners/collaborations directly
Requires drug development experience setting global regulatory strategy in alignment with cross functional peers to support company's corporate goals
Minimum of 10+ years of proven experience in a strategic leadership role with strong project management skills
Experience interfacing with major government regulatory authorities
Strong communication and proactive negotiation skills
Communicate effectively and articulate complex ideas in an easily understandable way
Ability to successfully work in a fast-paced, demanding and collaborative environment
Travel up to approximately 5%
Benefits
Bonus
Stock
Benefits
Other applicable variable compensation
Company
Summit Therapeutics, Inc.
Summit Mission Statement: To build a viable, long-lasting health care organization that assumes full responsibility for designing, developing, trial execution and enrollment, regulatory submission and approval, as well as successful commercialization of patient, physician, caregiver, and societal-friendly medicinal therapy intended to: improve quality of life, increase potential duration of life, and resolve serious medical healthcare needs.
201-500 employees
H1B Sponsorship
Summit Therapeutics, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2024 (6)
2023 (1)
Funding
Current Stage
Public CompanyTotal Funding
$1.79BKey Investors
CARB-XEurofarmaBiomedical Advanced Research and Development Authority (BARDA)
2025-10-21Post Ipo Equity· $500M
2024-09-11Post Ipo Equity· $235M
2024-06-03Post Ipo Equity· $200M
Leadership Team
Manmeet Soni
Chief Operating Officer and Chief Financial Officer
Recent News
Company data provided by crunchbase