491 regulatory affairs director jobs at 275 companies in United States
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Regulatory Affairs Director
United States
$150k-$175k/yr RemoteFull Time
4+ YOERegulatory affairs director with 4+ years medical device experience; manage submissions, registrations, listings; maintain regulatory files; support audits and labeling.
MS Office, Databases, Online research
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Director, Regulatory Affairs
Jersey City, New Jersey, United States
$213k-$233k/yr HybridFull Time
10+ YOE10+ years regulatory affairs experience; FDA and international regulatory knowledge; clinical regulatory content and submissions; strong communication; individual contributor.
eCTD, Regulatory submissions
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Director, Regulatory Affairs
New York City or Boston or San Francisco or Salt Lake City or Milton Park or Montréal or London
$208k-$281k/yr RemoteFull Time
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.
3mo
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Director, Regulatory Affairs
Durham, North Carolina, United States
OnsiteFull Time
10+ YOEMS or advanced degree; 10+ years in drug regulatory affairs; FDA interactions; submissions; leadership and cross-functional collaboration.
eCTD, Regulatory Submissions, Publishing
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Director, Regulatory Affairs
South San Francisco, California, United States
$225k-$263k/yr HybridFull Time
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.
eCTD, Regulatory_submissions
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Director, Regulatory Affairs
Somerset, New Jersey, United States
$194k-$254k/yr HybridFull Time
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
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Regulatory Affairs Director
Gaithersburg, Maryland, United States
$179k-$268k/yr HybridFull Time
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.
3w
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Regulatory Affairs Director
Gaithersburg, Maryland, United States
$179k-$268k/yr HybridFull Time
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.
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Director, Regulatory Affairs
Chicago or Austin or Houston
$160k-$180k/yr HybridFull Time
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.
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Director, Regulatory Affairs
United States
RemoteFull Time, Temporary
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.
Veeva RIM, Microsoft Office
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Director, Regulatory Affairs
Littleton, Colorado, United States
$177k-$266k/yr OnsiteFull Time
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.
2mo
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Director, Regulatory Affairs
California, United States
$240k-$275k/yr RemoteFull Time
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.
3w
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Director Regulatory Affairs
Houston, Texas, United States
OnsiteFull Time
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.
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Director, Regulatory Affairs
South San Francisco, California, United States
$275k-$280k/yr HybridFull Time
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.
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Director, Regulatory Affairs
Arlington, Virginia, United States
$108k-$133k/yr HybridFull Time
5+ YOEBachelor's degree; 5-10 years energy and environment policy experience; trade association experience a plus.
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Senior Director, Regulatory Affairs
United States
$259k-$317k/yr OnsiteFull Time
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.
FDA, CDER, CBER, CDRH, EMA, eCTD, 21 CFR, ICH, BLA, NDA, MAA, IND, CTA, RAC, RAPS, PDUFA
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Sr. Director, Regulatory Affairs
Richmond, Virginia, United States
$158k-$263k/yr HybridFull Time
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
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Director, Regulatory Affairs, Strategy
Bothell or Seattle or United States
$220k-$260k/yr OnsiteFull Time
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
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Executive Director, Regulatory Affairs
Boston, Massachusetts, United States
$281k-$344k/yr HybridFull Time
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.
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Senior Director, Regulatory Affairs
Brisbane or California
$216k-$241k/yr OnsiteFull Time
12+ YOEPhD/PharmD with 12+ years or BS/MS/MSN with 14+ years in regulatory affairs; experience leading BLA/NDA/MAA submissions, FDA/EMA interactions, eCTD/CTD knowledge, regulatory writing, and cross-functional leadership.
CTD, eCTD
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