Global Regulatory Lead - Oncology (Phase 1-2)
Januxrx
Janux Therapeutics, Inc. is seeking a Senior Director, Global Regulatory Affairs to provide strategic regulatory leadership across the clinical-stage oncology pipeline, guiding early development through registration and aligning cross-functional teams in a fast-paced environment. This hands-on leader will coordinate IND/CTA planning, health authority interactions, and global regulatory strategy across programs, influencing trial design and ensuring timely, high-quality regulatory deliverables. #J-18808-Ljbffr Januxrx
$240k - $275k
San Diego, CAClinical - Regulatory /Full-Time /HybridThe Senior Director, Global Regulatory Affairs will... ...Janux’s clinical-stage oncology pipeline, supporting... .... This individual will lead global regulatory strategy... ...clinical development (Phase 1/2), coordinating multiple...RegulatoryFull timeSummer workWork at officeRemote workRelocationRelocation packageShift work$189k - $246k
Travere Therapeutics is seeking a Director, Regulatory Affairs Strategy in San Diego, responsible for global regulatory strategies for clinical development programs. The role involves collaboration with numerous departments and interaction with health authorities like...RegulatoryRemote job- ...seeking a medical leader to head oncology programs and provide comprehensive... ...medical oversight across multiple trial phases in San Diego. The role involves... ...clinical development, strong regulatory knowledge, and experience leading late‑phase studies, with prostate...Regulatory
$150k - $180k
...seeking a Senior Manager of Pharmacovigilance to oversee global pharmacovigilance for oncology products based in San Diego. The role requires 12 years... ...pharmacovigilance, managing ICSR reports, and ensuring regulatory compliance. The ideal candidate will have a strong...Regulatory$258.68k - $313.46k
...careers.bms.com/working-with-us.Sr Director, Global Regulatory Strategy, NeuroscienceWill be a key... ...regional regulatory staff as Global Regulatory Lead and US Regional Regulatory Lead on... ...include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours...RegulatoryHourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaRemote workFlexible hoursShift work$227.42k - $275.58k
...of an emergent biotech with the global expertise and resources of a leading innovator in oncology. Our mission is to develop transformative... ..., Clinical Pharmacology, Regulatory, and CMC teams.Ensure biology... ...unlimited paid sick time, up to 2 paid volunteer days per year, summer...RegulatoryHourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaImmediate startRemote workFlexible hours- ...Diego seeks a Senior Program Leader to drive a complex global development program for a regulated medical... ...electronics, software, and systems integration, ensuring regulatory readiness and market launches across phased releases. You will coordinate a matrix of engineering...Regulatory
$239.9k - $399.8k
...expertise on Late phase clinical trials,... ...such as regulatory affairs, pharmacovigilance... ...across 2-3 study team(s)... ...safety monitoring.· Lead peer-to-peer interactions... .../eligible in oncology or equivalent... ...to Global Development Lead... ...(such as TN, O-1, H-1B, etc.) is...RegulatoryPermanent employmentFull timeInternshipH1bLocal areaVisa sponsorshipWork visaRelocation package2 days per week$150k - $180k
...seeking a Senior Manager of Pharmacovigilance to manage global pharmacovigilance activities for oncology products. This role includes ensuring compliance... ...small-molecule oncology products, and a strong grasp of regulatory standards. The position offers a salary range of $15...Regulatory- Acadia Pharmaceuticals seeks a Director, Regulatory CMC to lead global regulatory strategies for small molecules, from development through commercialization. You will guide IND/CTA filings, NDA/MAA submissions, and lifecycle management, coordinating with R&D, Manufacturing...Regulatory
- HDR is seeking a TMT Program Manager to lead multidisciplinary teams from conception to completion, ensuring project success across a global client base. The role involves advising clients on technical and regulatory aspects while expanding HDR’s program management services...Regulatory
$142k - $192.5k
...Overview Intuit is the global financial technology platform... ...We're looking for a Lead, SOX Program Strategy &... ...visible areas of ownership: (1) serving as the primary... ...controls; and (2) owning and operationalizing... ...team. Monitor the evolving regulatory environment (PCAOB, SEC)...RegulatoryWork experience placementWork at office$270k - $320k
...candidates include (1) rinzimetostat,... ...complex 2 (PRC2) via the... ...an experienced oncology physician to serve... ...rigor, guiding regulatory interactions, and... ...the ability to lead effectively in a... ...programs across all phases of development... ...monitoring oversight for global clinical trials,...RegulatoryH1b$120k - $160k
...Industry Recognition NMHC - #1 Fastest Growing Developer; #2 Fastest Growing Building;... ...opportunity for a Permit Lead to join our Design for... ...and clear interpretation of regulatory mandates. This role is instrumental... ...to support building phasing plans and design processes...RegulatoryTemporary workWork experience placementMonday to FridayFlexible hours$257k - $275k
...Supply Chain will lead and execute Janux’s... ...supply strategy across Phase 1–3 programs, with a... ...uninterrupted global supply of investigational... ...CMC, Quality, and Regulatory to align supply... ...experience supporting Phase 2 and Phase 3... ...required; oncology therapeutic area background...RegulatoryFull timeSummer workRelocationRelocation package$110.52k - $138.15k
...Research Associate - Oncology - Southern CaliforniaICON is a global healthcare... ...and the client's regulatory inspections Contribute... ...activities Lead site engagement... ...visits. Atleast 2 years monitoring... ...clinical trials.1+ years early... ...through close-out phases Experience activating...RegulatoryFull timeInterim roleLocal areaRemote work$295.9k
...development strategy of oncology program(s). Reporting to the Global Development Product Lead, the successful... ...for integrating regulatory, statistical and... ...clinical scientists Late phase drug development... ...an average of 2.5 days per week.... ...sponsorship (such as TN, O-1, H-1B, etc.) is...RegulatoryPermanent employmentFull timeH1bLocal areaVisa sponsorshipWork visaRelocation package2 days per week$274.5k
...clinical trial(s) and lead subteams in... ...trial and regulatory documents, in collaboration... ...with the Global Development Team... ...experience. Hematology/Oncology clinical... ...across multiple phases of clinical development... ...an average of 2.5 days per week... ...(such as TN, O-1, H-1B, etc.) is...RegulatoryPermanent employmentFull timeH1bLocal areaVisa sponsorshipWork visaRelocation package2 days per week- ...with the medical product leads. This individual will... ...Management, Quality Assurance, Regulatory, Clinical Supply,... ..., and other applicable global regulatory requirements... ....Experience in early-phase oncology trials, and/or immunology... ...lead of a minimum of 1 prior successful product...Regulatory
$295.9k
...a senior role within the Pfizer Oncology Late Stage Development organization... ...portfolio within 4404 (PD-1 VEGF). This role is responsible for leading the Global Product Team (GPT) for the product... ...the Disease Area HeadIntegrates regulatory and statistical input into clinical...RegulatoryPermanent employmentFull timeTemporary workH1bLocal areaVisa sponsorshipWork visaRelocation package$184.06k - $223.04k
...Development is part of the Global Research organization in BMS and leads late stage clinical,... ...late stage portfolio for regulatory, translational development... ...including hematology, oncology, immunology, cardiovascular... ...Biomarker, Late Phases, Translational MedicineSummaryLocation...RegulatoryHourly payFull timeSummer workLive inLocal areaRemote workFlexible hours- ...Werfen seeks a Head of Quality and Regulatory Affairs in San Diego to lead quality systems, regulatory strategy, and post-market surveillance for Autoimmunity... ...teams, and ensure compliance with FDA, ISO, and global standards. You will oversee submissions, training,...Regulatory
- ...Danaher operating company, seeks a Senior Trade Compliance Specialist to lead cross-functional trade compliance across US, Canada, and Europe. You will manage daily activities, ensure regulatory alignment, and drive cost-saving initiatives in a dynamic life sciences manufacturing...Regulatory
- ...on compliance, and strengthen internal controls across departments. The role requires collaboration with senior staff and ongoing regulatory knowledge. Responsibilities include training, document reviews, and risk analysis to prevent trade disruptions while maintaining...Regulatory
- ...protocol, applicable regulatory requirements, ICH-GCP... ...on oversight of early-phase oncology studies, including complex... ...ICH-GCP, applicable global regulatory requirements... ...managing Phase 1 and/or other early-phase... .... Hands-on experience leading clinical trial execution...RegulatoryContract workSummer holidayLocal area
- ...Vice President of Regulatory Affairs, Founding Regulatory Leader, Ophthalmology & Retina... ...on a founding role in building and leading its global regulatory function. This senior leadership... ...in supporting products through Phase 2 and Phase 3 clinical development, and...Regulatory
$190.54k - $230.89k
...emergent biotech with the global expertise and resources of a leading innovator in oncology. Our mission is to... ...quality practices and regulatory compliance in the adoption... ...strongly desiredMinimum of 2 years of experience in... ...study reports across phases 1 to 4 trials and...RegulatoryFull timeTemporary workImmediate startFlexible hoursWeekend workAfternoon shift- ...seeking a Senior Director, Clinical Supply Chain to lead the global clinical supply strategy across Phase 1-3. This hands-on leadership role ensures... ...partnering with Clinical Operations, CMC, Quality, and Regulatory. The ideal candidate has deep biologics experience,...Regulatory
- ...Clinical Supply Chain to lead and execute our clinical supply strategy across Phase 1-3 programs, ensuring uninterrupted global supply of... ...Operations, CMC, Quality, and Regulatory to align planning, manufacturing... ...deep biologics experience, oncology background preferred,...Regulatory
$170k - $182k
...Manager, Clinical Contracts to lead negotiation and management of clinical... ...and Finance in support of our oncology programs in San Diego. This... ...contract lifecycle experience, global Phase 1-3 trial knowledge, and a strong focus on regulatory compliance, with a competitive...RegulatoryContract work
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