495 director regulatory affairs jobs at 277 companies in United States
2mo
Save
Mark Applied
Hide
2mo
Regulatory Affairs Director
United States
$150k-$175k/yrRemoteFull Time
VitalConnect: Develops wearable biosensor patches for continuous wireless patient monitoring.
4+ YOERegulatory affairs director with 4+ years medical device experience; manage submissions, registrations, listings; maintain regulatory files; support audits and labeling.
Eikon TherapeuticsNASDAQ: EIKN: Discovers drugs using advanced live-cell imaging and protein tracking.
10+ YOE10+ years regulatory affairs experience; FDA and international regulatory knowledge; clinical regulatory content and submissions; strong communication; individual contributor.
New York City or Boston or San Francisco or Salt Lake City or Milton Park or Montréal or London
$208k-$281k/yrRemoteFull Time
RecursionNASDAQ: RXRX: Developing medicines using an AI-native drug discovery platform.
10+ YOE10+ years pharma experience with 8+ years in global regulatory affairs; experience with major health authorities and regulatory submissions; strong regulatory strategy, communication, and cross-functional collaboration skills.
CytokineticsNASDAQ: CYTK: Develops muscle-directed medicines for cardiovascular and neuromuscular diseases.
7+ YOE10+ years of drug development, 7+ years in regulatory affairs; biotech/pharma; cardiovascular focus; Bachelor's required; advanced degree preferred; strong global regulatory and eCTD experience.
Legend BiotechNASDAQ: LEGN: Develops cell therapies for the treatment of cancer.
7+ YOERequires PharmD, PhD, or equivalent science/healthcare degree; 7+ years in regulatory affairs and IND, CTA, BLA, or MAA submissions; global regulatory strategy, biologics, and cell therapy experience preferred.
IND, CTA, BLA, MAA, FDA, E-Verify, Form I-9, TCR-T, NK
AstraZenecaLondon Stock Exchange: AZN: Global biopharmaceutical developing and manufacturing prescription medicines.
3+ YOEBachelor's in a science field with ≥3 years regulatory strategy experience, knowledge of regulatory affairs across development stages, experience with major health authority interactions, strong strategic thinking and communication skills.
AstraZenecaLondon Stock Exchange: AZN: Researches, develops, and manufactures prescription medicines for major diseases.
3+ YOE3+ years regulatory affairs/drug development experience in pharma/biotech, bachelor\u0002s in life sciences or related, experience with IND/CTA/NDA/BLA filings, regulatory strategy and health authority interactions.
Jupiter Power: Developing and operating utility-scale battery energy storage systems.
6+ YOE6+ years in regulatory affairs, market policy, utility regulation, or related fields; Bachelor's degree; knowledge of wholesale electricity markets, interconnection, and regulatory frameworks; experience with filings and stakeholder processes; strong analytical and communication skills.
AskBio: Developing AAV-based gene therapies for genetic and complex disorders.
10+ YOEBachelor’s degree and 10+ years of regulatory affairs or drug development experience required. Requires clinical-stage submissions, health authority interactions, global strategy, Veeva RIM or similar systems, and strong communication skills.
3D SystemsNYSE: DDD: Provides 3D printing hardware, materials, and digital manufacturing services.
12+ YOE5+ MgmtBachelor's in life science or related; 12+ years progressive regulatory affairs experience (5+ in medical devices) with 5+ years leadership; deep FDA and EU MDR knowledge; RAC preferred; experience with patient-specific/additively manufactured devices.
Nektar TherapeuticsNASDAQ: NKTR: Develops polymer-based medicines for autoimmune and inflammatory diseases.
12+ YOEBachelor's in life sciences (advanced degree preferred), 12+ years regulatory affairs in biotech/pharma with leadership, experience leading IND/CTA/NDA and global dossier management, strong RFI and agency interaction skills, deep ICH GCP knowledge.
Houston Methodist: A non-profit health system providing comprehensive hospital and specialty medical services.
8+ YOEAdvanced degree in scientific field,8+ years regulatory affairs experience in FDA-regulated industry,experience with IND/IDE/NDA/BLA/PMA/510(k) submissions,RAC-DRUG required,RAC-DEVICE preferred,leadership and submission management skills.
Calico: Researching aging biology to develop longevity-improving therapies.
10+ YOEMaster's in life science required (PhD preferred); 10+ years regulatory affairs experience with IND/CTA experience required; experience with NDA/BLA/MAA preferred; strong FDA/EMA knowledge; ability to lead cross-functional teams; onsite 4+ days/week.
ArdelyxNASDAQ: ARDX: Discovers and develops medicines for unmet medical needs.
12+ YOEBachelor's degree in life sciences or related field and 12+ years of regulatory affairs experience. Requires BLA, NDA, or MAA submission leadership, FDA expertise, team management, and global regulatory experience.
McKessonNew York Stock Exchange: MCK: Distributes pharmaceuticals and provides healthcare information technology solutions.
13+ YOE6+ Mgmt13+ years experience with 6+ years in leadership; deep FDA/DEA regulatory knowledge; ability to lead regulatory strategies, licensing, and AI governance.
Regulatory software, AI governance tools, Regulatory intelligence tools
LeonaBioNASDAQ: LONA: Clinical-stage biopharmaceutical developing novel small molecule therapies.
8+ YOERequires 8+ years in biopharmaceutical regulatory affairs, 5+ in global strategy, and ownership of a major US or US/EU submission. Requires FDA meeting leadership, global regulatory expertise, strategic judgment, and cross-functional influence.
EU CTR/CTIS, NDA, BLA, Fast Track, Breakthrough Therapy, PRIME, FDA, EMA, ICH
Beeline Medicines: A clinical-stage biotechnology developing precision therapies to transform the lives of people with autoimmune and inflammatory diseases.
15+ YOE5+ MgmtAdvanced degree in life sciences required; 15+ years regulatory affairs experience with 5+ years as Global Regulatory Lead; hands-on experience with IND/CTA/NDA/MAA submissions; FDA/EMA interactions; strong communication and leadership.
Kyverna TherapeuticsNASDAQ: KYTX: Developing cell therapies for patients with autoimmune diseases.
15+ YOEBachelor's in a scientific discipline required (advanced degree preferred); 15+ years progressive regulatory affairs experience in pharma/biotech with advanced therapy and global regulatory experience; proven labeling, BLA/MAA, and health-authority engagement skills.