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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.
1mo
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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
3w
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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.
4w
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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
3mo
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Associate Director, Regulatory Affairs
Boston, Massachusetts, United States
$171k-$204k/yr RemoteFull Time
6+ YOE6+ years in Regulatory Affairs; US/global strategy; IND/CTA/NDA/BLA/MAA experience; knowledge of GxP, ICH, FDA guidance; strong communication; US-based remote with quarterly travel to Boston.
3mo
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Associate Director, Regulatory Strategy
Boston, Massachusetts, United States
$192k-$209k/yr HybridFull Time
7+ YOE7+ years regulatory affairs in pharma/biopharma; I&I experience; IND/CTA and NDA/BLA/MAA submissions; FDA interactions; EMA experience; early-to-mid stage biotech exposure.
1mo
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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 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 Lead, Oncology
Boston or Cambridge
$154k-$243k/yr HybridFull Time
6+ YOEBachelor's required (scientific preferred), 6+ years pharmaceutical industry regulatory experience, knowledge of global regulatory requirements, submission experience, strong communication and strategic skills.
1mo
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Sr. Manager/Associate Director, Regulatory Affairs
Menlo Park or Waltham or United States
$161k-$208k/yr HybridFull Time
8+ YOEBachelor's in life sciences required, advanced degree preferred. RAC a plus. 8+ years regulatory affairs experience in biotech/pharma with IND/CTA and global submissions, FDA interactions, and strong regulatory planning skills.
5d
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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.
3w
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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 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.
3w
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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.
2mo
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Associate Director, Global Regulatory, CMC
Norwood, Massachusetts, United States
$143k-$257k/yr OnsiteFull Time
8+ YOEBS/MS/PhD in molecular biology, pharmaceutics, chemistry, chemical engineering or related field; 8+ years pharma/biotech experience; 5+ years regulatory CMC experience; strong knowledge of global CMC regulations and CTD format.
1mo
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Staff Regulatory Affairs Associate (Digital Health & AI Technologies)
Boston, Massachusetts, United States
$170k-$220k/yr OnsiteFull Time
8+ YOEBachelor's degree, 8+ years medical device regulatory affairs experience, experience with SaMD and AI/ML-enabled products, strong knowledge of FDA and EU MDR pathways and submissions (Q-Subs, 510(k), De Novo).
1mo
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Staff Regulatory Affairs Associate (Digital Health & AI Technologies)
Boston, Massachusetts, United States
$170k-$220k/yr OnsiteFull Time
8+ YOEBachelor's in related field (advanced preferred), 8+ years regulatory affairs experience in medical devices with SaMD/AI/ML experience, strong FDA and EU MDR knowledge, and experience leading 510(k)/De Novo/Q-Submissions.
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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Regulatory Coordinator - Breast Oncology
Boston or Maine or Vermont or New Hampshire or Massachusetts or Connecticut or Rhode Island
$56k-$62k/yr HybridFull Time
0+ YOEBachelor's degree or 1 year as a Dana-Farber Associate Regulatory Coordinator; 0-1 years clinical research or medical/scientific experience preferred; proficiency with Microsoft applications and databases; knowledge of medical terminology; strong communication and organizational skills.
Microsoft applications, databases
1mo
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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.
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