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Director, CMC Lead
Bedford or Waltham
$225k-$250k/yr HybridFull Time
10+ YOE5+ Mgmt10+ years CMC experience with drug-device combination products, 5+ years CMC leadership, bachelor's required (advanced degree preferred), deep CMC/regulatory knowledge, strong communication and cross-functional leadership.
3mo
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CMC Lead
United States
$150k-$215k/yr RemoteFull Time
10+ YOELead CMC strategy for drug and device; 10+ years of drug development; strong regulatory and manufacturing experience.
GMP, Analytical Method Development, Stability Testing, CDMO Management, Regulatory Submissions
1mo
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CMC Regulatory Lead
Redwood City, California, United States
$200k-$240k/yr OnsiteFull Time
7+ YOE7+ years hands-on regulatory CMC experience, experience leading CMC strategy for cell therapies, IND/CTA experience, ability to prepare CMC dossiers and lead health-authority interactions; life sciences degree preferred.
3mo
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Director, Global CMC Regulatory
Redwood City, California, United States
$211k-$264k/yr OnsiteFull Time
15+ YOE15+ years in pharma/biotech drug development; 5+ years global CMC regulatory; deep CMC expertise; leadership across US, EU, APAC, LATAM.
GMP, FDA, EMA, ICH, CMC
5d
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Director, Regulatory CMC
Boston, Massachusetts, United States
$182k-$275k/yr HybridFull Time
10+ YOEBS in life sciences, 10+ years regulatory CMC or related pharma experience, experience with peptides and injectable dosage forms, ability to author CMC submissions and coordinate cross-functional inputs.
3mo
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Director, Regulatory Affairs – CMC
United States
$204k-$244k/yr RemoteFull Time
12+ YOEBS degree; advanced degree preferred; 12 years regulatory affairs experience; gene therapy and CMC regulatory strategy expertise.
Regulatory Submissions, CMC, IND, IMPD, BLA, MAA
1w
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Senior Associate, Regulatory CMC
Durham or United States
RemoteFull Time
5+ YOE5+ years pharmaceutical/biotech CMC experience, expertise in biologics/cell therapy CMC, CMC writing and submissions, regulatory inspection support, and risk-based lifecycle management.
1mo
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Director, Regulatory CMC
Somerville, Massachusetts, United States
$220k-$235k/yr HybridFull Time
10+ YOE10+ years biopharma CMC regulatory experience for biologics/gene therapies; bachelor’s or master’s in life sciences; experience with post-approval CMC submissions, GMP and global regulatory frameworks; strong communication and cross-functional skills.
3w
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Scientist I - CMC
United States
$32-$40/hr RemoteFull Time
Supports CMC regulatory documentation and lifecycle management; familiarity with cGMP, ICH, CTD authoring preferred; bachelor's in related field or equivalent experience preferred; strong written/verbal communication and organizational skills.
Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Adobe Acrobat
2mo
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CMC dossier leader
Framingham or Waltham or Cambridge
$149k-$215k/yr HybridFull Time
5+ YOEPhD or MS in pharmaceutical-related field; minimum 5 years CMC development experience; proven CMC dossier authoring; knowledge of regulatory and digital transformation in pharma; leadership and collaboration skills; Vault RIM, Word and Adobe proficiency.
Vault RIM, Word, Adobe
2w
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Senior Director, CMC Management (5549)
California or Oregon or Washington
$161k-$274k/yr RemoteFull Time
8+ YOEAdvanced degree (PhD/MS) with 8+ years relevant biologics CMC experience, regulatory/ICH knowledge, multi‑functional CMC expertise, project and people management, English and basic Mandarin communication.
3mo
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Director, CMC Product Development – Biologics
Boston or Durham
$217k-$227k/yr HybridFull Time
10+ YOEPhD in relevant field; 10+ years CMC biologics; expertise in formulation, fill-finish, regulatory submissions; strong cross-functional leadership.
DoE, QbD, CMC, Regulatory Submissions
4w
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Senior Vice President, CMC
San Diego, California, United States
$306k-$445k/yr OnsiteFull Time
15+ YOE15+ MgmtBS required (PhD preferred); 15+ years senior CMC management experience in biologics; track record in global manufacturing, supply chain, CMO qualification, regulatory CMC submissions, and leadership of technical teams.
2mo
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Director / Senior Director, Lirentelimab CMC Team Leader
Redwood City, California, United States
OnsiteFull Time
14+ YOEDirector/ Senior Director-level CMC leadership for lirentelimab; 14+ years in biotech with BLA/submission experience; cross-functional team leadership.
CMC, Regulatory, Quality, Bioanalytics, Process Development, Manufacturing
1w
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Director, CMC Regulatory Affairs
New York City or Salt Lake City or London or Montréal or Milton Park or Boston or San Francisco
$208k-$281k/yr RemoteFull Time
8+ YOE8+ years CMC regulatory experience for small molecules, BA/BS or advanced degree, RAC preferred, deep knowledge of US, EU and ex-US CMC regulations, track record authoring INDs/NDAs, cross-functional collaboration.
1d
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Associate Director, Regulatory CMC
San Carlos, California, United States
$180k-$211k/yr RemoteFull Time
10+ YOEBachelor's in a scientific discipline, minimum 10 years vaccine/biotech experience, experience authoring CMC sections (BLA preferred), IND/IMPD experience, development/manufacturing exposure, advanced regulatory knowledge, strong communication.
LIMS, SAP, TrackWise, Veeva
1mo
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Senior Manager, Regulatory CMC
Brisbane, California, United States
$140k-$214k/yr RemoteFull Time
6+ YOEBA/BS in a scientific field with minimum 6 years of regulatory affairs experience; strong US regulatory knowledge; CMC development in biologics preferred; proficient in regulatory information management systems (Veeva Vault RIM a plus).
Veeva Vault RIM
3w
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Director, RA CMC
North Chicago, Illinois, United States
$161k-$305k/yr HybridFull Time
10+ YOE3+ MgmtBachelor's in relevant field required; 10+ years biopharma experience with 3+ years enterprise leadership and 5+ years RA exposure; experience developing global regulatory CMC strategies and interfacing with agencies.
4d
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Director/ Senior Director, Regulatory CMC
Boston, Massachusetts, United States
$200k-$265k/yr OnsiteFull Time
8+ YOEDoctorate preferred; ≥8 years Regulatory CMC biologics experience with FDA sCDER interactions, global submissions, lifecycle management, and biologics/combination product development.
1d
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Director, CMC Stability
Norwood, Massachusetts, United States
$167k-$301k/yr OnsiteFull Time
15+ YOEDegree in life sciences or related field, 15 years relevant experience (or 10 years with PhD), deep stability science and CMC judgment, experience with stability strategy, regulatory submissions, leadership and cross-functional collaboration.
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