Summit Therapeutics, Inc. · 3 days ago
Senior Director, Regulatory Affairs - Global Regulatory Leader
Menlo Park, CA
Full-time
Onsite
Director/Executive
$238K/yr - $298K/yr
12+ years expSummit Therapeutics Inc. is a biopharmaceutical oncology company dedicated to improving quality of life through innovative therapies. The Senior Director of Regulatory Affairs - Global Regulatory Leader will develop and implement global strategies for IND/CTA approvals and lead regulatory initiatives for oncology products.
BiotechnologyHealth CareMedical DeviceTherapeutics
Responsibilities
Leads global regulatory strategies for assigned products/indications through all phases of development. May include doing so in context of development collaborations and/or partnerships
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
May lead the Labeling Regulatory Team for given product(s)/indication(s)
Proactively anticipates and mitigates regulatory risks
Demonstrates excellent understanding of drug development and leadership behaviors consistent with level
Develops and implements acceleration strategies as appropriate
Accountable for ensuring that corporate goals are met with respect to assigned projects
Acts independently under direction of Vice President of Regulatory Affairs
Based on experience and scientific strengths, expands TA knowledge of TA; provides coaching and mentoring for other regulatory members
Will have direct reports and contributes to the performance management for other RA team members
Makes decisions regarding regulatory work processes or operational plans and schedules in order to achieve the program objectives established
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 12+ years' experience in pharmaceutical 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
Requires drug development experience in US & EU
Minimum of 5+ years of proven experience in a strategic leadership role with 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
Experience developing and implementing successful global regulatory strategies
Attention to detail, accuracy, and confidentiality
Clear and concise oral and written communication skills
Critical thinking, problem solving, ability to work independently
Must be able to effectively multi-task and manage time-sensitive and highly confidential documents
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 Board Member
Recent News
2025-12-09
2025-12-05
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