Senior Regulatory Affairs Manager - Oncology Submissions
Oterra
ORIC Pharmaceuticals, Inc. is seeking a proactive Regulatory Affairs professional to advance oncology product development. You will collaborate with regulatory operations, quality, CMC, nonclinical and clinical teams to support high-quality regulatory submissions. The ideal candidate has a scientific background, strong writing and project management skills, and experience preparing INDs and DSURs. You will help ensure compliance with FDA/ICH guidelines and maintain regulatory archives, while #J-18808-Ljbffr Oterra
$240k - $275k
...Diego, CAClinical - Regulatory /Full-Time /HybridThe Senior Director, Global Regulatory Affairs will provide strategic... ...’s clinical-stage oncology pipeline, supporting... ...Regulation (CTR) and CTA submissions.Serve as the primary... ....Experience managing regulatory risk and...SeniorFull timeSummer workWork at officeRemote workRelocationRelocation packageShift work- Jobtailor in San Diego seeks a Senior Medical Writer with oncology focus to provide strategic and operational... ...writing for complex clinical and regulatory documents. You will lead authoring... ...end development for health authority submissions. Requirements include a PhD...Senior
- CorDx Inc. is seeking an experienced Regulatory Affairs Manager in San Diego, CA to lead regulatory strategy and FDA submissions for IVD products throughout development and lifecycle. You will collaborate with R&D, Clinical, Quality, and Manufacturing to ensure compliant...Senior
- ...questions in healthcare. Job Type: Full time Job Title: Senior Regulatory Affairs Manager Location: Onsite - Atlanta, or San Diego... ...play a crucial role in leading and managing the regulatory submissions for CorDx medical device products, including 510(k) and...SeniorFull timeFlexible hours
$175k - $205k
Sr Manager/Assoc Director, CMC Regulatory Affairs San Diego, CA, South San Francisco, CA or remote... ...-stage precision oncology company focused on discovering... ...Regulatory Affairs, the Senior Manager or Associate... ...support through QC review of submission components, including...SeniorTemporary workCasual workLocal areaRemote workWorldwideFlexible hours$132k - $172k
...science and service for rare patients.Position Summary:The Senior Manager, CMC Regulatory Affairs is responsible for providing strategic and operational... ...management. Responsibilities:CMC Regulatory Strategy, Submissions & Dossier DevelopmentDevelop and implement CMC...SeniorFull timeTemporary workRemote work$132k - $172k
...science and service for rare patients.Position Summary:The Senior Manager, CMC Regulatory Affairs is responsible for providing strategic and operational... ...will be responsible for driving CMC regulatory submissions, managing Health Authority interactions related to CMC...SeniorFull timeTemporary workRemote workWorldwide$184.06k - $223.04k
...late stage portfolio for regulatory, translational development and life cycle management. Translational... ...including hematology, oncology, immunology, cardiovascular... ...effortsSupports regulatory submissions and regulatory... ...department, to governance and senior leadership bodies, and...SeniorHourly payFull timeSummer workLive inLocal areaRemote workFlexible hours$258.68k - $313.46k
...with-us.Sr Director, Global Regulatory Strategy, NeuroscienceWill... ...will impact BMS, regulatory affairs or projects and provides... ...with the regulatory product managers (submissions) and regulatory operations... ...Chat with Ripley.R1603594 : Senior Director, Global Regulatory...SeniorHourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaRemote workFlexible hoursShift work- Protego Biopharma is seeking a Senior Director, Regulatory Affairs (CMC) to lead the global CMC regulatory... ...molecule program advancing toward NDA/MAA submission. The role combines strategy,... ...Analytical Development, Clinical, and Program Management. #J-18808-Ljbffr Protego BioSenior
- Erasca is seeking a Sr Manager/Assoc Director, CMC Regulatory Affairs to lead regulatory activities for IND/CTA development and ongoing trials. The role... ...regulatory compliance, and coordinating global submissions. The ideal candidate will have 5+ years in biotech/pharma...SeniorRemote job
- Synchron is seeking a Senior Director of Regulatory Affairs for their San Diego operations. This position involves overseeing regulatory strategies... ...-computer interface (BCI) platform development and managing submissions to regulatory bodies. The ideal candidate will have...Senior
$205k - $268k
...Job Summary:The Director / Senior Director of Regulatory Operations is responsible... ...This role owns end-to-end submission planning, execution, and delivery... ...regulatory information management platform. The ideal... ...owner.Partner with Regulatory Affairs Leads, Clinical...SeniorRemote workFlexible hours$172.5k - $222.5k
...What You’ll Be Responsible For Circle is looking for a Senior Manager to join the Regulatory Assurance team who will help to create a central global... ...timely remediation of any identified findings. Supporting submission of regulatory reports, validating data accuracy, and...SeniorFlexible hours- Stryker Corporation is looking for a Director of Regulatory Affairs to lead regulatory strategy and compliance efforts. This fully remote... ...position involves coordination with FDA and overseeing regulatory submissions in the pharma/biotech field. Candidates should have...Remote job
$228k - $245k
Overview The Director, Global Regulatory Affairs will play a critical role in developing and implementing... ...more programs. Lead the preparation, submission, and maintenance of regulatory filings... ...and to inform strategic planning. Manage regulatory timelines and ensure timely...SeniorFull timeSummer workWork at officeRemote workRelocation packageMonday to Friday$210k - $240k
Senior Director, Regulatory Affairs-CA Requisition ID: 1032 Salary Range: $210,000.00 To $240,000.00 Annually... ...updates and manufacturing‑related submissions, working closely with cross‑... ...programs and product updates Author and manage IDE, PMA, and PMA supplement...SeniorFull timeFlexible hours$154.5k - $193.25k
...biopsy, pharmacogenetics, and more. Job Summary: The Senior Manager, Quality & Regulatory Affairs is responsible for overseeing the development, implementation... ...initiatives, manages audit readiness and regulatory submissions, and develops a high-performing team that supports...SeniorTemporary workWork at officeLocal areaWorldwideFlexible hours$228k - $315k
...Therapeutics is seeking an experienced Senior Director, Regulatory Affairs (CMC) to join our small regulatory... ...study and on toward NDA/MAA submission. This is a senior, hands-on role requiring... ..., personally driving submissions, managing CDMO and consultant partners, and...SeniorFull timeWork at officeMonday to Friday- Cooley LLP is seeking a Litigation Marketing Senior Manager - Regulatory to lead and execute strategic marketing and client development programs... ...thought leadership, campaigns, events, and awards submissions, with responsibilities spanning plan development, stakeholder...Senior
- Mesa Labs is seeking a Senior Manager, Quality & Regulatory Affairs to oversee the development, implementation, and continuous improvement of the organization... ...regulatory initiatives, manages audit readiness and regulatory submissions, and develops a #J-18808-Ljbffr Mesa LabsSenior
- ...Therapeutics, Inc. in San Diego, CA, is seeking a Director of Regulatory Affairs to lead global regulatory strategy, oversee NDA filings,... ...health authority interactions. The role includes managing submission documents, lifecycle planning, and supervising external publishing...
- Fernridge Group in San Diego is seeking a Senior Compliance Officer/Deputy Chief Compliance Officer to partner with the General Counsel... ...comprehensive compliance program, lead risk assessments, and manage regulatory filings, policies, and training. #J-18808-Ljbffr Fernridge...Senior
- ...Senior Vice President, Head of Compliance About the Company Accomplished provider of personal loans & related services... ...Risk Officer, and oversee all aspects of compliance, including managing regulatory exams, audits, and reporting. The role also involves collaborating...Senior
$270k - $320k
...Diego is seeking an experienced Medical Director or Senior Medical Director focused on oncology clinical development. This role will lead medical... ...-stage clinical trials and shape strategies for regulatory submissions. The ideal candidate has an MD, board certification...Senior- ...Leader to guide SAS programming across clinical data analyses and submissions. You will lead teams and coordinate biometrics activities,... ...mentor programmers, drive vendor collaborations, and oversee regulatory deliverables such as DSURs, IB updates, and e-submission...Senior
- ...Myers Squibb subsidiary, is seeking a Senior Director of Clinical Data Management in San Diego, CA. You will lead... ...portfolio, drive strategy for NDA submissions, and manage the DM team and CRO... ...requires 12+ years in data management, oncology experience, and strong expertise...Senior
- Barrington James in San Diego seeks a Regulatory Affairs Specialist/Senior Specialist to lead complex global submissions (FDA, EU Notified Bodies) and guide product lifecycle... .... Strong communication and project management skills are essential to translate science into...Senior
$170k - $240k
Litigation Marketing Senior Manager - Regulatory Cooley is seeking a Litigation Marketing Senior Manager - Regulatory to join the Marketing team... ...members driving the execution of directory and awards submissions Lead the development and execution of thought leadership...SeniorTemporary workWork at officeImmediate startFlexible hoursWeekend work- ...SUMMARYWe are seeking a Senior or Executive... ...our early-stage oncology portfolio. This... ..., translational, regulatory, and clinical operations... ...of IND submissions, including protocols... ...dose decisions, and management of study conduct... ...with Regulatory Affairs, CMC, Clinical Operations...SeniorFlexible hours
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