3w
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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.
2w
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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.
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.
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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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.
2w
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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.
1w
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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.
1mo
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Director, RA CMC
Waltham or North Chicago
$161k-$305k/yr OnsiteFull Time
10+ YOE3+ MgmtBachelor's in pharmacy/biology/chemistry/engineering 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.
3mo
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Director/Senior Director, CMC, Drug Substance
Boston or Needham
$222k-$303k/yr HybridFull Time
10+ YOEPhD in Chemistry or Chemical Engineering with 10+ years API CDMO experience; regulatory CMC writing; CDMO selection and tech transfer; extensive cGMP knowledge.
CDMO management, CMC, Regulatory writing, GxP
1mo
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Associate Director, Regulatory Affairs CMC
Boston, Massachusetts, United States
$165k-$180k/yr HybridFull Time
12+ YOEBachelor's in relevant science required; 12+ years regulatory CMC experience (10+ with advanced degree); direct CMC experience for biologics/cell & gene therapies; knowledge of FDA/EMA/ICH and eCTD submissions.
eCTD
3w
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Associate Director, Regulatory CMC (Biologics)
Waltham, Massachusetts, United States
$182k-$208k/yr HybridFull Time
6+ YOEMaster's or PhD in life sciences, 6+ years CMC experience with minimum 3+ years regulatory CMC in biologics, cGMP and global regulatory submission expertise (FDA/EMA/ICH), experience authoring Module 3 and combination product submissions.
1mo
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Director, Regulatory Affairs CMC
Waltham, Massachusetts, United States
$207k-$253k/yr OnsiteFull Time
12+ YOEBS in life sciences or equivalent experience (advanced degree preferred); minimum 12 years relevant experience with 8-10 years regulatory CMC experience; strategic CMC regulatory expertise; experience with global health authorities; strong communication and negotiation skills.
2w
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Manager, CMC Project Management
Waltham, Massachusetts, United States
$140k-$180k/yr OnsiteFull Time
5+ YOEBachelor's degree required; 5+ years biotech/pharma experience in CMC/Technical Operations or project management; familiarity with GMP, external partner management, risk identification, and cross-functional coordination.
2w
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CMC Asset Lead, Nephrology
Cambridge or Research Triangle Park or San Francisco
$204k-$281k/yr HybridFull Time
12+ YOE12+ years' experience in matrix leadership with CMC/supply chain or life cycle management; BS required, advanced degree preferred; alliance and financial management experience; strong strategic, communication and risk-management skills.
3w
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Associate Director / Director, CMC Project Management
Waltham, Massachusetts, United States
$220k-$245k/yr OnsiteFull Time
8+ YOE5+ MgmtBachelor's in a scientific field required (advanced preferred); 8+ years biotech/pharma experience with ≥5 years CMC project management; experience with biologics, CDMOs, regulatory CMC familiarity; strong project and stakeholder management skills.
4w
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Director, Regulatory Affairs CMC
Waltham, Massachusetts, United States
$200k-$240k/yr HybridFull Time
12+ YOEBachelor's in a scientific discipline required (advanced degree preferred). 12+ years Regulatory Affairs with hands-on CMC leadership across clinical through registration; experience with small-molecule NCEs, regulatory submissions, health authority meetings, and Veeva required.
Veeva
2w
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Associate Manager CMC Regulatory Compliance (301589)
Billerica, Massachusetts, United States
$78k-$117k/yr HybridFull Time, Part Time
1+ YOEBachelor's degree in life science,1+ years pharmaceutical or academic experience with regulatory/CMC knowledge,ability to develop CMC strategies and prepare CMC dossiers.
2w
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Director/Senior Director, CMC Operations
Cambridge, Massachusetts, United States
$210k-$320k/yr OnsiteFull Time
10+ YOEAdvanced degree in life sciences or engineering,10+ years CMC development experience with leadership, expertise in nucleic acid/LNP manufacturing and analytics, regulatory submission experience, strong risk management and communication skills.
HPLC, NGS, PCR, ELISA, MS, RNA quantitation
3w
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Associate Director, Regulatory Affairs CMC
Waltham, Massachusetts, United States
$170k-$230k/yr OnsiteFull Time
7+ YOE7+ years Reg Affairs CMC pharmaceutical experience, hands-on CTD Module 3 authorship, familiarity with FDA/EMA/ICH guidance, experience with IND/NDA/MAA submissions, strong written and verbal communication.
1mo
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Associate Director, Regulatory Affairs, CMC
United States or Philadelphia or Cambridge
$171k-$231k/yr HybridFull Time
8+ YOEAdvanced degree in a relevant scientific discipline, 8+ years industry experience including 5+ years in Regulatory Affairs CMC, experience with regulatory submissions and health authority interactions, strong communication and cross-functional leadership.
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