Senior Manager, Regulatory Affairs jobs in United States
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Summit Therapeutics, Inc. · 12 hours ago

Senior Manager, Regulatory Affairs

positionPalo Alto, CA
timeFull-time
remoteOnsite
senioritySenior Level
money$174K/yr - $204K/yr
date7+ years exp

Summit Therapeutics Inc. is a biopharmaceutical oncology company focused on improving quality of life and addressing unmet medical needs. The Senior Manager of Regulatory Affairs will oversee regulatory activities for clinical studies, manage submissions to regulatory agencies, and collaborate with cross-functional teams to ensure compliance and successful project execution.

BiotechnologyHealth CareMedical DeviceTherapeutics
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H1B Sponsor Likelynote

Responsibilities

Provide ownership of molecule and study-level regulatory activities, including global clinical trial applications (CTAs) and IND submissions, review and approval of investigator document packages and associated FDA submissions, and manage other regulatory aspects of the studies as necessary
Contribute and drive the regulatory content and strategy for BLA, NDA or marketing authorization submissions
Provide regulatory guidance internally on study-team decisions
Update study team of regulatory activities in the context of study team management meetings
Manage and track queries and commitments with regulatory agencies, collaborate with subject matter experts to provide written responses to queries, provide periodic status updates regarding unfulfilled conditions/commitments
Collaborate with cross-functional study team for planning of regulatory documents, including health authority meetings and responses to health authority queries
Support processes by which regulatory submissions are reviewed, finalized, and signed-off
Manage the record of regulatory/ethics submissions and approvals across all studies
Manage document archive processes
Support global regulatory submissions and strategic planning as applicable
All other duties as assigned

Qualification

Regulatory Affairs experienceFDA regulations knowledgeClinical trial applicationsPharmaceutical industry experienceMS Office proficiencyChinese languageInterpersonal skillsWritten communicationOral communicationDetail-orientedOrganizational skills

Required

BA/BS degree in the biological or health related sciences required
Minimum of 3+ years of experience in regulatory affairs
Minimum of 7+ years of pharmaceutical, biotechnology, or life sciences industry experience
Knowledgeable of US FDA and international pharmaceutical guidance's, regulations, drug development process, and industry-standard practices
Possess strong written, oral communications
Demonstrate proven interpersonal skills and experience working cross-functionally throughout the organization
Detail-oriented, ability to work proactively, organize, prioritize, and delegate assigned projects
Proficient user of standard MS Office suite (e.g., Word, Excel), experience using electronic document management systems, and document review tools

Preferred

Master's, PhD or PharmD
Experience interacting with CROs in the management of ex-US CTAs towards clinical trial activations
Ex-US health authority interactions, meetings etc
Knowledge of Chinese

Benefits

Bonus
Stock
Benefits
Other applicable variable compensation

Company

Summit Therapeutics, Inc.

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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.
dateFounded in 2003
location
Abingdon, Oxfordshire, GBR
people-size201-500 employees
web-link
https://www.smmttx.com/

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 Company
Total Funding
$1.79B
Key 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

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Manmeet Soni
Chief Operating Officer and Board Member
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Recent News

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