ORIC PharmaceuticalsNasdaq: ORIC: Develops oncology therapies addressing mechanisms of drug resistance.
6+ YOEBachelor's in a scientific field required, advanced degree preferred; 6+ years regulatory experience preferred; experience preparing IND/DSUR/CTA and FDA meeting requests; strong writing, project management, and regulatory knowledge.
Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Veeva RIM
Huisong Pharmaceuticals: Manufacturer of natural ingredients for pharmaceutical and food industries.
5+ YOEBachelor's in a scientific field, 5+ years regulatory affairs experience in dietary supplements/botanicals/TCM, PCQI required, HACCP preferred, audit and FDA regulatory experience.
Neurocrine BiosciencesNASDAQ: NBIX: Develops pharmaceuticals for neurological, endocrine, and psychiatric disorders.
2+ YOE2+ MgmtDegree in life/health sciences (BS/MS/PharmD/PhD) with 2–6+ years industry experience (regulatory experience required), knowledge of FDA/ICH guidance, project management, leadership, and strong communication skills.
JenaValve Technology: Developing transcatheter heart valve systems for aortic disease treatment.
5+ YOEBachelor's in a scientific discipline, 5+ years medical device regulatory affairs experience, people management experience, expert knowledge of global regs for Class II/III devices, MDSAP and quality systems, and ability to interpret guidance and direct project teams.
AlconNYSE: ALC: Manufactures ophthalmic surgical equipment and vision care products.
5+ YOE3+ MgmtBachelor's degree or equivalent experience, 5 years relevant experience, 3 years leadership, experience with regulatory submissions, GxP/SOP compliance, medical device/pharma support, and fluent English.
RED Digital Cinema: Manufactures high-end digital cinematography cameras and professional video accessories.
10+ YOEBachelor's in a related field, 10+ years in chemical regulatory/compliance, strong knowledge of global regulations (REACH, TSCA, RoHS, Prop 65), experience with registrations, CMS and compliance documentation, strong communication and project skills.
Travere TherapeuticsNASDAQ: TVTX: Developing and selling therapies for rare kidney diseases.
6+ YOE6+ years regulatory affairs experience in pharma/biotech; bachelor\u0002s in life sciences required (advanced degree preferred); experience with IND/CTA and global submissions; knowledge of FDA/EMA/ICH; ability to travel up to 10%; able to perform onsite work in San Diego.
Acadia PharmaceuticalsNASDAQ: ACAD: Develops and sells medicines for neurological and rare diseases.
12+ YOE8+ Mgmt12+ years in Regulatory Operations/Regulatory Affairs; 8+ years leadership; experience with regulatory systems and submissions; Veeva Vault RIM and eCTD tools; travel; Bachelor's in life sciences.
Veeva Vault RIM, eCTD tools, regulatory information management, publishing platforms
ErascaNASDAQ: ERAS: Developing precision oncology medicines to treat cancer patients.
5+ YOEUndergraduate degree required (advanced preferred),5+ years regulatory affairs experience in pharma/biotech, experience with IND/CTA and global submissions, strong organization, communication, and regulatory knowledge.
Rivian and Volkswagen Group Technologies: A joint venture developing software and technology solutions for electric vehicles.
5+ YOEBachelor's in a technical field, 5+ years in automotive certification/product safety/homologation, expertise in one or more regulatory domains, familiarity with WVTA/US self-certification, proficiency with Jama/Codebeamer/Flow, ability to author DVPs and manage regulation-to-code traceability.
Axos FinancialNYSE: AX: Provides digital-first banking and diverse financial services to customers.
10+ YOE5+ Mgmt10+ years in banking/financial services or compliance,5+ years leading RegTech or compliance technology,experience with AI, automation, analytics, and regulatory programs.
Microsoft Copilot, Power BI, Tableau, SQL, Python, Power Automate, n8n, Salesforce, Archer, ServiceNow, GRC platforms, AI/LLM technologies
University of California, Irvine: Public research university offering higher education and academic degrees.
3+ YOEExperience submitting IRB applications; 3-5 years RAC or assistant RAC; strong English communication; regulatory knowledge; ability to manage multiple tasks and maintain confidentiality.
Manager, Regulatory Affairs for Chemistry Manufacturing & Controls (CMC)
North Chicago or Irvine or Waltham
$110k-$209k/yrHybridFull Time
AbbVieNYSE: ABBV: Develops and sells innovative pharmaceutical and biopharmaceutical medicines.
6+ YOEBachelor's in pharmacy/biology/chemistry/pharmacology/engineering,6+ years biopharmaceutical experience,regulatory affairs experience preferred,strong written and oral communication skills.
2+ YOEBachelor's degree required (Master's preferred),2+ years in higher education compliance/accreditation,knowledge of accreditation standards,project management and documentation skills,Microsoft Office proficiency.
Balt: Manufacturer of medical devices for treating neurovascular diseases
1.5+ YOEBA/BS in scientific/technical field,1.5+ years in regulated industry,experience with regulatory documentation,MS Office and Adobe Acrobat skills,ability to manage regulatory systems and coordinate cross-functional partners.
Microsoft Office, Adobe Acrobat, Product Lifecycle Management Systems