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174 regulatory associate jobs at 107 companies in Berkeley, CA

1mo
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Regulatory Assoicate
San Francisco, California, United States
$100k-$130k/yr HybridFull Time
Gridware
Gridware: Real-time sensor platforms for power grid monitoring and safety.
3+ YOEExperience with regulatory filings, utilities, and regulatory communication; ability to produce regulatory materials and analyses.
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6d
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Regulatory Affairs Associate
San Francisco, California, United States
$38/hr OnsiteFull Time
Heluna Health
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
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2mo
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Associate Director, Regulatory Systems
Redwood City, California, United States
$186k-$233k/yr HybridFull Time
Revolution Medicines
Revolution MedicinesNASDAQ: RVMD: Developing precision oncology therapies for RAS-addicted cancers
8+ YOE8+ years in Regulatory Systems; experience with Veeva RIM and DocuBridge; GxP validation; cross-functional collaboration; regulatory submissions knowledge.
Veeva RIM, DocuBridge, eTMF, GxP validation tools
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2mo
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Senior Associate, Regulatory Affairs
Philadelphia or San Francisco
OnsiteFull Time
Dispatch Bio
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.
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2mo
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Associate Director, Regulatory CMC
Palo Alto or Princeton or Miami
$194k-$199k/yr HybridFull Time
Summit Therapeutics
Summit TherapeuticsNASDAQ: SMMT: Developing oncology therapies to improve patient quality of life.
6+ YOEBachelor’s degree in chemistry, pharmacy, engineering, or biochemistry; 6+ years Regulatory CMC experience; experience with biologics; strong FDA/EU regulatory knowledge; experience preparing CMC submissions (IND/IMPD/BLA/MAA). Mandarin desirable.
Microsoft Word, Microsoft Excel, Document management systems
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3w
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Regulatory Affairs Associate (Principal) - Medical Devices
Cupertino, California, United States
OnsiteFull Time
Apple
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.
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1mo
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Associate Director Regulatory Affairs, Oncology
Upper Providence or Waltham or Rockville or Durham or Cambridge or San Francisco
$139k-$231k/yr HybridFull Time
GSK
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.
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2w
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Associate Director, Regulatory Affairs
South San Francisco, California, United States
$201k-$234k/yr HybridFull Time
Cytokinetics
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.
eCTD
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3w
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Associate Regulatory Operations Director
Alameda, California, United States
$158k-$223k/yr OnsiteFull Time
Exelixis
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%.
Veeva RIM
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1mo
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Associate Director, Regulatory Strategy
South San Francisco or Princeton
$170k-$230k/yr HybridFull Time
Kardigan
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.
eCTD
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1mo
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Sr. Manager/Associate Director, Regulatory Affairs
Menlo Park or Waltham or United States
$161k-$208k/yr HybridFull Time
Oruka Therapeutics
Oruka TherapeuticsNASDAQ: ORKA: Develops long-acting biologics for chronic skin and inflammatory diseases.
8+ YOEBachelor's in life sciences required, advanced degree preferred. RAC a plus. 8+ years regulatory affairs experience in biotech/pharma with IND/CTA and global submissions, FDA interactions, and strong regulatory planning skills.
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2mo
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Associate Director, Regulatory Affairs (Strategy, Hematology Oncology)
Brisbane, California, United States
OnsiteFull Time
Nurix Therapeutics
Nurix TherapeuticsNASDAQ: NRIX: Develops targeted protein degradation medicines for cancer and inflammation.
8+ YOE8+ years in regulatory affairs strategy; BS in life sciences; strong FDA/EMA/ICH knowledge; experience in regulatory submissions and cross-functional collaboration.
MS Project, Smartsheet, Microsoft Excel
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2mo
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Associate Director, Regulatory Affairs (on-site)
Alameda, California, United States
$149k-$297k/yr OnsiteFull Time
Abbott
AbbottNYSE: ABT: Manufactures medical devices, diagnostics, and nutritional health products.
5+ YOEBachelor's degree; 5-7 years in regulated industry; regulatory experience preferred; RAC or equivalent certification preferred; strong leadership and cross-functional collaboration skills.
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2mo
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Associate Director, Regulatory CMC
San Carlos, California, United States
$180k-$211k/yr HybridFull Time
Vaxcyte
VaxcyteNASDAQ: PCVX: Developing vaccines to prevent and treat bacterial diseases.
10+ YOEBachelor's in a scientific field; 10+ years in vaccine/biotech; experience drafting CMC submissions; knowledge of FDA/EMA/ICH; strong project management and communication.
LIMS, SAP, TrackWise, Veeva
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1w
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Associate Regulatory Counsel, Privacy
Mountain View or Seattle or San Francisco or Washington
$217k-$315k/yr OnsiteFull Time
Google
GoogleNASDAQ: GOOGL: Provides online search, advertising, cloud computing, and consumer electronics.
3+ YOEJD or equivalent, admitted to the bar in the hiring state, 3+ years attorney experience, experience advising on global privacy and data protection, strong communication and critical thinking.
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1mo
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Bank Accounting and Regulatory Reporting Senior Associate
United States or Canada or Columbus or Austin or San Francisco or New York City
$106k-$146k/yr RemoteFull Time
Upstart
UpstartNasdaq: UPST: AI-powered lending marketplace for consumer and automotive loans.
5+ YOEBachelor's in accounting/finance or equivalent, 5+ years in accounting/regulatory reporting at a regulated institution, experience with Call Reports/FR Y-series, reconciliations, audits, and regulatory filings; CPA preferred.
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1mo
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Associate Director, Regulatory Affairs Advertising and Promotion
Foster City, California, United States
$205k-$225k/yr HybridFull Time
Mirum Pharmaceuticals
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.
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1w
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Accreditation and Regulatory Specialist
Saint Helena, California, United States
OnsiteFull Time
Adventist Health
Adventist Health: Faith-based healthcare provider offering hospital and clinical services.
2+ YOEAssociate degree and 2 years healthcare experience required; regulatory/compliance and project management experience preferred; Lean/Six Sigma or GE Change Management certification preferred.
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2mo
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Associate Director, Regulatory Affairs Project Planning & Coordination
Princeton or San Diego or San Francisco
$154k-$193k/yr HybridFull Time
Acadia Pharmaceuticals
Acadia PharmaceuticalsNASDAQ: ACAD: Develops and sells medicines for neurological and rare diseases.
8+ YOEBachelor’s degree in life science; 8+ years regulatory drug development; global submissions experience; willing to travel.
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1w
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Associate Director, Global Regulatory Affairs Clinical Strategy - Job ID: 1998
Palo Alto, California, United States
$185k-$205k/yr HybridFull Time
Ascendis Pharma
Ascendis PharmaNASDAQ: ASND: Develops long-acting prodrug therapies for rare diseases and oncology.
8+ YOE8+ years regulatory experience, Bachelor's degree required, experience with IND/CTA/IMPD filings, knowledge of ICH and regional requirements, ability to lead cross-functional teams and mentor staff.
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