230 regulatory associate jobs at 129 companies in Holbrook, MA
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Regulatory Reporting Associate
Stamford or Orlando or Providence or Toronto or United States or Canada or North America
$90k/yr HybridFull Time
3+ YOE3+ years in regulatory/compliance/risk functions, working knowledge of regulatory frameworks, strong analytical and stakeholder skills, ability to interpret regulations, and proficiency with Microsoft Office (Excel, Word, PowerPoint).
Microsoft Office, Microsoft Excel, Microsoft Word, Microsoft PowerPoint
2d
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Associate Director, Regulatory Affairs
United States or Cambridge or Philadelphia
$171k-$231k/yr HybridFull Time
6+ YOEBachelor's degree and 6+ years in Regulatory Affairs, including 8+ years in biotech or pharmaceutical industry; regulatory filings, strategy, project management, communication, and regulatory guidance experience required.
word processing, spreadsheets, databases, online research
2mo
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Regulatory Strategy Associate Director
Boston, Massachusetts, United States
$168k-$252k/yr HybridFull Time
8+ YOEBachelor's in biology/chemistry or related; typically 8 years regulatory experience in pharma/biotech; expertise with global/regional regulatory frameworks, health authority submissions, and ability to lead regulatory strategy and mentor teams.
2d
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Associate Director, Regulatory Affairs
Cambridge or Philadelphia or Cambridge or Philadelphia or Boston
$171k-$231k/yr HybridFull Time
Bachelor's degree, 6+ years in Regulatory Affairs and 8+ years in biotech or pharmaceutical industry; regulatory filings, strategy, project management, communication, and regulatory interpretation experience required.
Investigational New Drug (IND), Clinical Trial Applications (CTAs), New Drug Applications (NDAs), spreadsheets, databases
3mo
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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
2mo
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Associate Director, Regulatory Science
Boston, Massachusetts, United States
$190k-$240k/yr HybridFull Time
US regulatory strategy and execution experience for biologics/ATMPs; strong knowledge of US CFR/FDA; IND/BLA submission experience; team leadership and regulatory submission project management; PharmD or PhD required.
2mo
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Associate Director, Regulatory Affairs
United States or New York or Boston
$190k-$200k/yr HybridFull Time
10+ YOEBachelor's or Master's required, 10+ years regulatory drug development experience, eCTD and submission authoring experience, deep FDA knowledge, ability to travel up to 10%.
eCTD, e-publishing systems
2w
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Associate Director, Regulatory Affairs
Boston, Massachusetts, United States
$175k-$219k/yr HybridFull Time
8+ YOE4+ MgmtRequires a bachelor's degree with 8+ years, master's with 6+ years, or doctorate with 3+ years in a relevant life sciences field, plus 4+ years of management and regulatory affairs experience.
FDA, HIPAA, Next Generation Sequencing (NGS)
1w
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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.
4w
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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%.
3w
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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
3w
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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.
3w
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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
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.
4d
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Associate Director, Regulatory Affairs - Advertising/Promotion (REMOTE)
Boston, Massachusetts, United States
RemoteFull Time
7+ YOEBachelor's degree and 7+ years of pharmaceutical Regulatory Affairs experience, including labeling and advertising/promotional materials; requires regulatory interpretation, risk assessment, communication, and cross-functional leadership skills.
Veeva Vault, Veeva Vault PromoMats, electronic document management system
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