Regulatory Affairs Associate, Oncology Submissions
Summit Therapeutics Inc.
Summit Therapeutics Inc. is seeking an Associate of Regulatory Affairs to support day-to-day regulatory activities for assigned projects, including CTA/IND submissions and health-authority interactions. The role involves coordinating submissions, maintaining timelines, and collaborating with cross-functional teams under the RA Lead. The candidate should have a BA/BS in life sciences, regulatory affairs experience, and a solid understanding of FDA regulations, ICH guidelines, and GCP, with strong #J-18808-Ljbffr Summit Therapeutics Inc.
- Summit Therapeutics Inc. is seeking an Associate of Regulatory Affairs to support day-to-day regulatory activities for assigned projects, including preparation and compilation of submissions for regulatory agencies and coordination of submission timelines. You will work...Suggested
- ...Therapeutics Inc. is a biopharmaceutical oncology company focused on improving quality... ...addressing unmet medical needs. The Associate of Regulatory Affairs will support day-to-day regulatory... ...for assigned projects, including submissions, timelines, and archival maintenance...Suggested
- Summit Therapeutics Inc. is seeking an Associate of Regulatory Affairs to support day-to-day regulatory activities for assigned projects, including submissions to regulatory agencies and maintenance of submission timelines. The role involves coordinating with cross-functional...Suggested
$97k - $114k
.... is a biopharmaceutical oncology company with a mission focused... ...approved by any regulatory authority other than China... ...Overview of Role: The Associate of Regulatory Affairs will support the day-to-day... ...preparation and compilation of submissions for regulatory agencies,...SuggestedContract workFor contractorsFor subcontractor$97k - $114k
.... is a biopharmaceutical oncology company with a mission focused... ...approved by any regulatory authority other than China... .... Overview of Role: The Associate of Regulatory Affairs will support the day-to-day... ...preparation and compilation of submissions for regulatory agencies,...Suggested$90k - $180k
Abbott Laboratories is seeking a Senior Regulatory Affairs Specialist at their Santa Clara, CA location. This role involves supporting the... ...regulatory input for product lifecycles and handling submissions to regulatory authorities. The ideal candidate should have...$186k - $233k
...Medicines is a late-stage clinical oncology company developing novel targeted... ...pathway.The Opportunity:The Associate Director, Global Regulatory Affairs Project Management is an integral... ...Responsibilities:Project manages regulatory submissions from initiation through...Full timeWork at officeLocal area- Stanford Medicine's Department of Anesthesiology, Perioperative and Pain Medicine seeks a Clinical Trials Regulatory Specialist 1 to provide centralized regulatory support across a diverse clinical research portfolio. The role guides teams through HRPP/IRB processes and...
$145k - $167k
...diagnostic imaging. Learn MoreAbout The RoleJob Title: Senior Regulatory Affairs SpecialistLocation:Palo Alto, CA or Guilford, CT (Hybrid, 3... ...development and is responsible for ensuring regulatory submissions and registrations are authored and submitted to targeted business...Work experience placementWork at officeWorldwideWork visaNight shiftWeekend work3 days per week$186k - $233k
...Medicines is a late-stage clinical oncology company developing novel targeted... ...pathway. The Opportunity: The Associate Director of Regulatory Affairs will provide regulatory leadership... ..., and coordinate regulatory submissions, ensuring high quality and timeline...Full timeWork experience placementLocal area- ...Client, an American Biotechnology company, is looking for a Regulatory Affairs Specialist 4 for their Sunnyvale, CA/Hybrid location.... ...with international counterparts to support global regulatory submissions, approvals, and implementation rollouts. Requirements...
$55 - $60 per hour
...Job Title: Sr. Regulatory Affairs Specialist Location: Sunnyvale, CA, United States Type: Contract Compensation:... ...design/process changes. Prepare and maintain regulatory submissions, including U.S. FDA 510(k) premarket notifications, Letters...Contract workTemporary workLocal area$55 - $60 per hour
Job Details Job Title: Regulatory Affairs Specialist IV Location: Sunnyvale, California Type: 6 month contract Compensation: $55-60/hour... ...onsite Hours: 40.0 Overview Lead regulatory strategy and submissions for medical devices, supporting product development, design...Contract workLocal area$178.4k - $297.2k
Regulatory Affairs Associate (Principal) - Medical Devices Cupertino, California, United States Software and Services Imagine what you could do... ...Regulatory Affairs Associate to help drive strategy and submissions for health products. If you are passionate about the health...Relocation$115.86k - $133.01k
...Transfer and Tangible Research property Agreements, draft language that complies with University, Federal and other sponsors and other regulatory policies, requirements, and conditions. Negotiate other research‑related agreements that involve intellectual property,...Hourly payFull timeContract workCasual workWork at officeRemote work- ...Medicine is seeking a Clinical Trials Regulatory Specialist 1 to provide centralized regulatory... ...Study Start-Up and Regulatory Submissions. This position supports new clinical research... ...with anIRB. Knowledge of regulatory affairs, including FDA regulations, IRBreview...Local areaWorldwide
- ...Function of Position This role provides expert support for regulatory project management, strategic submissions, and cross-functional compliance activities in... ...and documentation. • Mentor and coach regulatory affairs specialists. • Track and report metrics on regulatory...Local areaWorldwideFlexible hours
$90k - $180k
...software, vessel closure devices and peripheral stents.This Senior Regulatory Affairs Specialist position is an on-site opportunity working out of... ...implications for approval.Determine and communicate submission and approval requirements.Participate in risk-benefit analysis...WorldwideShift work$81.5k - $141.3k
...is seeking a passionate, experienced Regulatory Affairs Specialist to join our Vascular Division... ...successful track record of preparing submissions and documentation in compliance with relevant... ...conducting regulatory assessments associated with design, manufacturing, supplier,...For contractorsShift work$100k - $200k
...Abbott is seeking a highly motivated and experienced Principal Regulatory Affairs Specialist to join our Vascular Division team on-site in... ...management initiatives, regulatory assessments, and global submissions. This individual will serve as a key regulatory partner to...For contractorsShift work$90k - $180k
...SCJob Type: Full timeCategory: Regulatory AffairsIndustry:... ...function of a Senior Regulatory Affairs Specialist is to provide support... .... Determine and communicate submission and approval requirements. Participate... ...safety issues and product-associated events are reported to...Work experience placementWorldwide$171k - $231.4k
...Medical Devices Operational Compliance Team (MD-OCC), the Sr. Regulatory Affairs Specialist will be working to build best in class products.... ...solving and possess practical hands-on knowledge of FDA submissions and reporting requirements across the product lifecycle for...For contractorsLocal areaFlexible hours$24 - $27.6 per hour
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Title: Compliance Analyst Location: Remote US - Must be available in PST hours Duration: 12+ months Compensation: $40-70/hr Work Requirements: US Citizen, GC Holders or Authorized to Work in the U.S. About this Featured Opportunity...Local areaRemote workFlexible hours- ...Job Overview A law firm seeks a Healthcare Regulatory Associate in Palo Alto. This role offers the opportunity to work on health innovation, representing companies from pre-formation to capital markets, including public health tech companies. Duties Advise on healthcare...Flexible hours
$120k - $150k
...Certificates, Waivers & COAs Partner closely with engineering and flight test teams to ensure compliance alignment early in design Regulatory Engagement Serve as primary Pivotal representative to: Aeronautical Authorities including FAA (and offices including AIR,...Work at officeLocal area- ...Sr. Regulatory Affairs Specialist We are searching for an experienced regulatory professional... ...a history of successful regulatory submissions, registrations, 510(k)'s and PMA... ..., especially the FDA, and regulatory associations. Stays abreast of global IVD regulations...
$211k - $250k
...and liver damage. Who You Are A regulatory affairs leader who owns global regulatory... ...serve as the project manager for major submissions, and act as the regulatory voice on the... ...biotech or pharmaceutical industry for Associate Director; 8 years for Director, including...Flexible hours$225k - $275k
...Who You Are You are an experienced regulatory affairs professional with expertise in early clinical... ...to the planning, preparation, and submission of high-quality regulatory submissions... ....D., or equivalent) preferred. For Associate Director, we expect 7+ years of...Flexible hours- ...The Senior Regulatory Affairs Specialist leads regulatory operations activities with a focus on global tender support, regulatory documentation... ..., Regulatory Operations, or international regulatory submissions. Experience managing complex cross-functional projects and...
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