151 regulatory associate jobs at 82 companies in Gardner, MA
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Associate Director Regulatory Affairs
Waltham, Massachusetts, United States
$163k-$200k/yr OnsiteFull Time
10+ YOE10+ years Regulatory Affairs in biopharma; BS in science; experience with INDs/CTAs/NDAs/MAAs; strong regulatory strategy and communication.
Microsoft Office, SharePoint
4d
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Associate Director, Regulatory Affairs
Cambridge, Massachusetts, United States
$170k-$195k/yr RemoteFull Time
7+ YOEBachelor’s degree in a scientific discipline required; 7+ years in pharmaceutical or biotech industry, including 4+ years in Regulatory Affairs. Oncology, global submissions, FDA NDA/BLA, leadership, and AI tool experience required or preferred.
FDA, AI
2mo
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Associate Director Regulatory Affairs, Oncology
Upper Providence or Waltham or Rockville or Durham or Cambridge or San Francisco
$139k-$231k/yr HybridFull Time
Develop and execute regional regulatory strategies for oncology assets, lead regional submissions and interactions with regulatory authorities, ensure compliance across product lifecycle, and work cross-functionally within global matrix teams.
1mo
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Associate Director, Global Regulatory Lead, Oncology
Boston or Cambridge
$154k-$243k/yr HybridFull Time
6+ YOELead global regulatory strategies for oncology programs, oversee major submissions, manage FDA interactions, collaborate cross-functionally, and mentor regulatory teams.
2mo
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Associate Director Global Regulatory Sciences - Oncology
Princeton or Cambridge
$173k-$210k/yr OnsiteFull Time
4+ YOEPharmaceutical regulatory experience; advanced scientific degree preferred; 4+ years pharma experience with 3+ years in regulatory affairs; experience preparing IND/NDA/BLA submissions and leading regulatory interactions with health authorities.
3w
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Associate Director, Global Regulatory Affairs
Waltham, Massachusetts, United States
$155k-$190k/yr HybridFull Time
5+ YOEPrepare and lead regulatory submissions (IND/CTA/NDAs/MAAs), provide regulatory strategy and guidance, monitor global regulations, and support cross-functional teams; travel ~10-15%.
2w
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Associate Manager CMC Regulatory Compliance
Billerica, Massachusetts, United States
$78k-$117k/yr HybridFull Time
1+ YOEBachelor's degree in life science, 1+ year pharmaceutical or academic experience, and regulatory or CMC knowledge. Requires CMC strategy, dossier, documentation, and strong written and verbal communication skills.
IMPD, IND
2w
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Associate Director / Director, Regulatory Affairs
Watertown, Massachusetts, United States
OnsiteFull Time
8+ YOEAdvanced regulatory affairs leader with 8+ years in biopharma, experience with FDA/EMA/ICH, IND/NDA/BLA submissions, agency interactions, project management, and oncology preferred.
2w
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Associate Manager CMC Regulatory Compliance
Billerica, Massachusetts, United States
$78k-$117k/yr HybridFull Time
1+ YOEBachelor's degree in life science and 1+ year of pharmaceutical or academic experience with regulatory or CMC knowledge. Strong communication and regulatory documentation skills required.
IMPD, IND, Module 1, R&D
1mo
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Associate Manager CMC Regulatory Compliance
Billerica, Massachusetts, United States
$78k-$117k/yr HybridFull Time
1+ YOEBachelor's in life science, 1+ years pharmaceutical or regulatory/CMC experience; experience preparing CMC dossiers, regulatory strategy, and health authority interactions; strong writing and communication skills.
2mo
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Associate Director, Regulatory Affairs Operations
Cambridge, Massachusetts, United States
$200k-$240k/yr OnsiteFull Time
7+ YOEBachelors in life sciences required; 7+ years regulatory affairs/operations experience in pharma/biotech; experience with RIMS/EDMS/Veeva Vault, eCTD, project planning tools and Microsoft Office; knowledge of FDA/EMA/ICH standards.
RIMS, EDMS, Veeva Vault Regulatory, eCTD, Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Microsoft Teams, Smartsheet, Microsoft Project
2mo
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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.
1mo
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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.
2mo
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Associate Director, Regulatory Affairs (Cambridge, MA, US, 02142)
Cambridge, Massachusetts, United States
$171k-$231k/yr OnsiteFull Time
8+ YOEBachelor's required with 6+ years in regulatory affairs and minimum 8 years in biotech/pharma; US regulatory filing and FDA interaction experience; strong communication, project management, and regulatory interpretation skills.
2w
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Regulatory Coordinator - Sarcoma Clinical Trials
Boston or Brookline or Maine or Vermont or New Hampshire or Massachusetts or Connecticut or Rhode Island
$56k-$62k/yr RemoteFull Time
0+ YOEBachelor's degree or one year as an associate regulatory coordinator; strong communication, organization, computer, database, medical terminology, and basic clinical trial knowledge preferred.
Microsoft applications, databases, Food and Drug Administration (FDA), Institutional Review Board (IRB), Investigational New Drug (IND), Investigational Device Exemption (IDE)
12h
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Associate Director, Global Regulatory Affairs Compliance
Cambridge or San Francisco or Boston
$190k-$210k/yr HybridFull Time
8+ YOEBachelor’s degree in a scientific or related discipline, 8+ years of pharmaceutical or biotechnology regulatory affairs experience, regulatory writing expertise, and strong organizational, communication, judgment, and collaboration skills.
21 CFR, ICH
2w
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Senior Associate Regulatory and Business Continuity
Princeton or Billerica or New Jersey
$103k-$125k/yr HybridFull Time
5+ YOEBachelor's degree in pharmacy, chemistry, or life science; 5–8 years of pharmaceutical industry experience; regulatory submissions, FDA eCTD standards, change control, TrackWise, Microsoft Office Suite, and Adobe Acrobat experience.
TrackWise, Microsoft Office Suite, Adobe Acrobat Professional, eCTD, SPLs
2mo
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Associate Director Global Regulatory Sciences - Oncology
Princeton or Cambridge
$173k-$242k/yr OnsiteFull Time
4+ YOEPhD/MD/PharmD/BS/MS in a relevant field; 4+ years pharmaceutical industry experience with 3+ years in regulatory affairs; experience preparing FDA submissions (IND/NDA/BLA); leadership, project management, and cross-functional collaboration skills.
2w
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Associate Director, Regulatory Data Management & Intelligence
Cambridge, Massachusetts, United States
$143k-$257k/yr OnsiteFull Time
12+ YOEBachelor's degree with 12+ years or master's degree with 10+ years in regulatory, data, or related fields; extensive Veeva Vault RIM experience and expertise in governance, structured regulatory data, integrations, and implementations.
Veeva Vault RIM, Tableau, Vibe Coding, Data Lake, AdPromo, Change Control, APIs, middleware, IDMP, xEVMPD
13h
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Associate Director/Director for Regulatory Affairs
Minnesota or Minneapolis or New Hope or Michigan or Wyoming or Allegan or Denver or Hendersonville or Waunakee or Lunenburg or Navarre or Foley or Round Lake
RemoteFull Time
7+ YOE2+ MgmtAdvanced life sciences or pharmacy degree; 7–10+ years in pharmaceutical or biotechnology Regulatory Affairs; proven FDA ANDA, IND, and NDA submission leadership; generic drug strategy expertise and strong project management skills.
Food and Drug Administration (FDA)
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