180 regulatory associate jobs at 104 companies in Colma, CA
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Regulatory Affairs Associate
San Francisco, California, United States
$38/hrOnsiteFull Time
Heluna Health: Supports population health through program management and fiscal sponsorship.
Coordinate and manage IRB submissions, maintain study documentation, draft SOPs, implement quality management, and provide regulatory guidance for biomedical intervention studies.
Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Microsoft Access, Trello
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
Dispatch Bio: Develops universal immunotherapy treatments for solid tumor cancers.
2+ YOEBachelor’s in life sciences; 2+ years Regulatory Affairs in biotech/pharma; oncology/IND experience; strong communication; regulatory submissions; FDA/ICH knowledge.
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.
Upper Providence or Waltham or Rockville or Durham or Cambridge or San Francisco
$139k-$231k/yrHybridFull Time
GSKLondon Stock Exchange: GSK: Develops and manufactures innovative vaccines and specialty medicines.
Develop and execute regional regulatory strategies for oncology assets, lead regional submissions and interactions with regulatory authorities, ensure compliance across product lifecycle, and work cross-functionally within global matrix teams.
CytokineticsNASDAQ: CYTK: Develops muscle-directed medicines for cardiovascular and neuromuscular diseases.
8+ YOEBachelor's degree required; 8+ years drug development including 5+ years regulatory affairs in biotech/pharma; knowledge of FDA/EMA/ICH and GxP; experience with IND/CTA/eCTD submissions and health authority interactions; strong communication and organizational skills.
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
ExelixisNASDAQ: EXEL: Discovers and commercializes innovative medicines for cancer treatment.
5+ YOEDeep knowledge of global regulatory submission requirements, experience planning and managing electronic submissions, Veeva RIM experience, strong communication and cross-functional collaboration skills; travel ~20%.
Kardigan: Developing precision medicines to treat and cure cardiovascular disease.
6+ YOEBachelor's in life sciences required; 6+ years regulatory affairs experience in biotech/pharma; experience with INDs/CTAs and eCTD submissions; knowledge of FDA/EMA/ICH guidance; strong communication and organizational skills.
Denali TherapeuticsNASDAQ: DNLI: Developing treatments for neurodegenerative diseases through brain-delivery technology.
12+ YOERequires 12 years related experience with a bachelor's degree, 10 with a master's, or 7 with a PhD; 5+ years project/program management, regulatory filings experience, Smartsheet proficiency, and cross-functional leadership.
BridgeBio PharmaNASDAQ: BBIO: Discovers and develops medicines for patients with genetic diseases.
7+ YOEPhD+7 years or BS/MS+10 years in CMC/regulatory with experience authoring global regulatory submissions, knowledge of FDA/EMA/ICH and cGMP, analytical method and stability understanding, strong communication and leadership.
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 Director, Regulatory Affairs (Onsite in S.SF - 3X/wk)
South San Francisco, California, United States
$198k-$257k/yrHybridFull Time
Zai LabNasdaq: ZLAB: Zai Lab develops therapies for oncology and immunology.
10+ YOEBachelor's in life sciences with ~10 years biopharma experience (8 years in regulatory); experience preparing INDs, supporting health authority interactions, and working with cross-functional clinical teams.