84 regulatory associate jobs at 45 companies in Capitola, CA
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Associate, Regulatory Affairs
Palo Alto, California, United States
$97k-$114k/yrOnsiteFull Time
Summit TherapeuticsNASDAQ: SMMT: Developing oncology therapies to improve patient quality of life.
Bachelor's degree in biological or health sciences, biopharmaceutical regulatory affairs experience, knowledge of drug development, FDA regulations, ICH guidelines, and Good Clinical Practice, plus strong communication and organizational skills.
Microsoft Word, Microsoft Excel, electronic document management systems, document review tools
Revolution MedicinesNASDAQ: RVMD: Developing precision oncology therapies for RAS-addicted cancers
10+ YOE10+ years in pharma/biotech drug development with 5+ years global CMC regulatory; experience with IND, IMPD/CTA, NDA, MAA submissions; strong US/EU/APAC GMP regulatory knowledge.
Regulatory Affairs Associate (Principal) - Medical Devices
Cupertino, California, United States
OnsiteFull Time
AppleNASDAQ: AAPL: Designs and sells consumer electronics, software, and online services.
Drive regulatory strategy and submissions for health and medical device products; collaborate with cross-functional teams to enable product launches within regulatory frameworks.
GondolaBio: Develops clinical-stage therapeutics for rare genetic diseases.
5+ YOEBachelor’s degree in a scientific discipline and 5–8 years of biotech or pharmaceutical regulatory experience. Requires hands-on NDA/BLA leadership, FDA interactions, submission project management, and CTD/eCTD knowledge.
CTD, eCTD, ICH, 21 CFR, PMP, NDA, BLA, IND, CTA, EMA, MAA, Health Canada, MHRA
Associate Director, Regulatory Affairs Advertising and Promotion
Foster City, California, United States
$205k-$225k/yrHybridFull Time
Mirum PharmaceuticalsNASDAQ: MIRM: Develops and commercializes therapies for rare liver diseases.
8+ YOE8+ years in Regulatory Affairs with 6+ years in advertising/promotion for prescription drugs/biologics; science degree; strong cross-functional and regulatory knowledge; excellent communication.
Associate Director, Regulatory Affairs (Robotics & Digital Solutions) - MedTech Surgery
Santa Clara, California, United States
$157k-$271k/yrHybridFull Time
Johnson & JohnsonNYSE: JNJ: Provides pharmaceutical products and medical technology healthcare solutions.
10+ YOE2+ MgmtBachelor's required (advanced degree preferred); 10+ years regulatory affairs in medical devices incl. software; 2+ years people-management; experience with FDA software/cybersecurity, US and EU MDR, and software-enabled device approvals.
Associate Director, Regulatory Affairs (Robotics & Digital Solutions) - MedTech Surgery
Santa Clara, California, United States
$157k-$271k/yrHybridFull Time
Johnson & JohnsonNYSE: JNJ: Develops and manufactures pharmaceutical drugs and medical devices.
10+ YOE2+ MgmtBachelor's required (advanced degree preferred), 10+ years regulatory affairs in medical devices (software-enabled systems), 2+ years people management, FDA and EU MDR experience, software/cybersecurity knowledge, experience with vision/robotics preferred.
US - Associate - Corporate - Healthcare – Regulatory
Boston or Chicago or Los Angeles or San Francisco or Redwood City or Washington
$225k-$435k/yrOnsiteFull Time
Latham & Watkins: Global law firm providing legal services for complex corporate matters.
3+ YOEMinimum 3 years healthcare regulatory experience including reimbursement and transactional due diligence; strong analytical and writing skills; experience with fraud and abuse counseling preferred.
Associate General Counsel, Competition & Regulatory
Menlo Park or Washington or New York City or San Francisco
$202k-$274k/yrOnsiteFull Time
MetaNASDAQ: META: Develops social networking platforms and virtual reality technologies.
5+ YOEJ.D. and U.S. state bar membership required, with 5+ years of antitrust legal experience, including merger reviews or inquiries, complex legal problem-solving, and global regulatory work.
Santa Clara or Idaho or Ohio or Tennessee or Texas
$230k-$250k/yrHybridFull Time
OkloNYSE: OKLO: Developing advanced fast fission nuclear power plants.
7+ YOEJ.D. and bar admission,7+ years energy regulatory experience with substantive FERC and State PUC practice, generator interconnection expertise, strong project and stakeholder management, and excellent communication.
Santa Monica or Foster City or El Segundo or Thousand Oaks
$127k-$164k/yrHybridFull Time
Kite PharmaNASDAQ: GILD: Developing engineered cell therapies to treat and cure cancer.
5+ YOEBS plus 5+ years or MS plus 3+ years in Regulatory Affairs or relevant industry experience; scientific degree preferred. Requires regulatory knowledge, organization, communication, and project management skills.
Stanford University: A private research university providing higher education and research.
2+ YOEAssociate degree plus 2 years related experience or bachelor's degree in a related field; clinical research, protocol, regulatory, project management, Microsoft Office, medical terminology, and communication skills required. Spanish is a plus.
Microsoft Office, HIPAA, FDA, Institutional Review Board, Good Clinical Practices
Gibson, Dunn & Crutcher: A global law firm hiring attorneys with experience in securities enforcement, regulatory investigations, and compliance matters.
Law school class years 2018–2022; experience in securities enforcement, regulatory investigations, and compliance matters; strong communication and critical thinking.
Karius: Genomic blood tests for rapid identification of infectious pathogens.
1+ YOEBachelor's degree or equivalent experience; 1–3 years in clinical research or regulatory documentation; familiarity with TMF/ISF, ICH-GCP, FDA requirements, Microsoft Office, and Google Workspace.
Trial Master File (TMF), Google Workspace, Google Sheets, Google Docs, Google Drive, Microsoft Office Suite, Investigator Site Files (ISFs), electronic Trial Master File (eTMF)
BaxterNYSE: BAX: Develops medical technologies and therapies for patient care.
10+ YOE7+ MgmtBachelor's degree in science, engineering, or a related technical field; 10+ years in quality or manufacturing; 7+ years managing teams; medical products, regulatory, GMP, cleanroom, and quality systems expertise.
Quality Management System (QMS), CAPA, Design Controls, Process Controls, GMP, ISO 7, ISO 8, Medical Device Regulation (MDR), Employee Stock Purchase Plan (ESPP), 401(k) Retirement Savings Plan (RSP)
Gilead SciencesNASDAQ: GILD: Develops and sells medicines for life-threatening infectious diseases.
2+ YOEBachelor's plus 10 years, master's plus 8 years, or PhD plus 2 years; statistical leadership, clinical trial expertise, regulatory communication, team leadership, and direct supervision experience required.
Predicine: Develops liquid biopsy cancer diagnostics and precision medicine solutions.
2+ YOERequires 2+ years supporting clinical trials, global trial and CRO/vendor experience, eTMF knowledge, study start-up, budget and audit support, regulatory knowledge, and a bachelor's degree in biology, life sciences, or related field.
Environment, Energy & Resources - Associate Attorney – Midlevel
Washington or Palo Alto or Anchorage or San Francisco or New York or Chicago or San Diego or Portland or Phoenix or Madison or Boise or Bellevue or Seattle
$190k-$390k/yrHybridFull Time
Perkins Coie: International law firm providing legal and business counsel.
3+ YOE3-6 years energy law experience; regulatory and transactional background; draft energy contracts; FPA familiarity; JD; bar admission or eligibility to waive.
AbbottNYSE: ABT: Manufactures medical devices, diagnostics, and nutritional health products.
3+ YOEBS in life sciences with 3+ years CRA/CRC experience (or equivalent), clinical trial/site monitoring experience, knowledge of GCP and regulatory practices, TMF maintenance, proficiency with Microsoft Suite, able to travel ~10-15%.