2mo
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Manager, Regulatory Affairs
Waltham, Massachusetts, United States
$116k-$160k/yr RemoteFull Time
Deciphera Pharmaceuticals: Developing targeted kinase inhibitors for the treatment of cancer.
6+ YOE6+ years pharma experience; 4+ years Regulatory Affairs; knowledge of regulatory requirements; strong communication; ability to manage multiple priorities.
2w
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Regulatory Affairs Manager
Palm Beach Gardens or Raynham or West Chester
$117k-$201k/yr HybridFull Time
6+ YOEBachelor's degree with 6+ years regulatory experience in medical device industry; experience with US/EU regulations; RAC preferred; ability to lead team, manage submissions, and interact with regulatory agencies.
1w
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Regulatory Compliance Manager
Lowell, Massachusetts, United States
$105k-$125k/yr OnsiteFull Time
3+ YOEBachelor's in Food Science, 3+ years food manufacturing/regulatory experience, 2+ years managing labeling and regulatory documentation, leadership experience, FDA/USDA/HACCP knowledge, Microsoft Office and ERP proficiency.
Microsoft Office, ERP systems, nutrition analysis/compliance software
1mo
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Senior Manager, Regulatory Lead
Boston or Cambridge or United States or Canada or Japan or China or Europe
$137k-$215k/yr OnsiteFull Time
4+ YOEBSc preferred; 4+ years pharmaceutical experience with 2+ years in regulatory strategy. Experience with regulatory submissions, FDA interactions, global regulatory requirements, strong communication and negotiation skills.
InterACT, Dragonfly
2d
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Manager, Regulatory Affairs
Stoughton, Massachusetts, United States
$132k-$158k/yr HybridFull Time
4+ YOEBachelor's required (Master's preferred),4+ years pharma/life sciences experience,strong regulatory knowledge,experience with document management and electronic publishing,Microsoft Office proficiency,excellent communication.
Microsoft Excel, Microsoft Outlook, Microsoft PowerPoint, Microsoft Word
2w
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Regulatory Affairs Manager
Palm Beach Gardens or West Chester or Raynham or Oberdorf or Zuchwil
$117k-$201k/yr HybridFull Time
6+ YOEBachelor's degree,6 years related experience in medical devices,knowledge of US/EU device regulations,RAC preferred,ability to manage regulatory submissions and teams,travel up to 10%.
2w
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Regulatory Affairs Manager
Palm Beach Gardens or West Chester or Raynham
$117k-$201k/yr HybridFull Time
6+ YOEBachelor's degree or equivalent,6+ years regulatory experience in medical devices,knowledge of US/EU regulations,RAC preferred,ability to lead teams and interact with regulatory agencies,travel up to 10%.
2d
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Manager, Regulatory Affairs
Cambridge, Massachusetts, United States
$115k-$135k/yr HybridFull Time
5+ YOEBachelor's degree in a scientific discipline; 5+ years biotech/pharma regulatory experience; IND and FDA meeting experience; regulatory submissions and RIMS familiarity; strong scientific writing and organizational skills.
Kivo, Veeva
1mo
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Manager, Regulatory Affairs
Burlington, Massachusetts, United States
$110k-$150k/yr OnsiteFull Time
8+ YOEBachelor's degree, 8+ years regulatory experience in medical devices, authored 510(k)/CE technical documentation, strong regulatory writing and interpretation skills, ability to support product development and mentor junior staff.
3w
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Manager, Regulatory Affairs
Cambridge, Massachusetts, United States
$100k-$143k/yr OnsiteFull Time
2+ YOEB.S. or M.S. with 2+ years regulatory experience; knowledge of IND/CTA/NDA/MAA submissions; experience in precision oncology/rare disease/CDx a plus; strong communication and regulatory strategy skills.
1mo
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Manager, Regulatory Affairs
Boston or San Francisco or Seattle
$135k-$150k/yr RemoteFull Time
5+ YOEBachelor's degree required; 5+ years pharma/biotech R&D experience including 3+ years in Regulatory Affairs; experience with IND and eCTD submissions, strong scientific interpretation, regulatory knowledge (FDA/ICH/EMA), and proficiency in MS Word, Excel, and Adobe Acrobat.
Microsoft Word, Microsoft Excel, Adobe Acrobat, eCTD
4w
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Senior Manager, Regulatory Affairs
Watertown, Massachusetts, United States
$145k-$215k/yr OnsiteFull Time
5+ YOE5+ years regulatory affairs drug development experience managing INDs/CTAs and designation requests; experience with EU CTR/CTIS; Bachelor’s degree in a scientific discipline required; strong regulatory writing, communication and cross-functional collaboration skills.
Clinical Trials Information System (CTIS), EU Clinical Trials Regulation (EU CTR)
2d
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Manager, Global Regulatory Strategy
Gaithersburg or Boston
$109k-$164k/yr HybridFull Time
5+ YOE5+ years regulatory affairs experience in pharma, bachelor's degree preferred (scientific/clinical), strong knowledge of drug development and regulatory policy, experience with NDA/BLA submissions, excellent communication and judgment.
3d
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Regulatory Compliance Senior Manager
Brookline, Massachusetts, United States
$138k-$157k/yr HybridFull Time
6+ YOE1+ MgmtBachelor's degree, 6+ years regulatory healthcare compliance experience, 1+ year management, CHC preferred (willing to obtain), knowledge of federal/state healthcare laws, strong communication and analytical skills.
3d
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Manager, Regional Regulatory Lead - LCM
King of Prussia or Waltham
$129k-$153k/yr HybridFull Time
5+ YOE5+ years regulatory/submission experience in biotech/pharma, 3+ years on developmental products, bachelor in life sciences, experience with health authority interactions, strategic thinking and cross-functional communication.
Veeva
3mo
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Policy & Regulatory Affairs Manager
Washington or Oakland or Boston
HybridFull Time
5+ YOE5+ years in public policy or regulatory affairs; strong policy/regulatory experience; excellent communication; cross-functional collaboration; ability to operate in ambiguity.
1w
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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.
1w
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1940 Act Regulatory Administration Manager
Los Angeles or Atlanta or Cincinnati or Milwaukee or New York or Minneapolis or Chicago or Boston or Philadelphia or Denver or Charlotte
$139k-$164k/yr HybridFull Time
8+ YOELaw degree and license to practice in jurisdiction, 8+ years related experience, knowledge of the Investment Company Act of 1940, ability to manage teams and complex projects, strong communication and regulatory drafting skills.
3mo
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Director, Regulatory Operations
Lexington, Massachusetts, United States
$206k-$227k/yr HybridFull Time
12+ YOE12+ years in biotech with 7+ years in regulatory operations; proficient with eCTD, Veeva RIM, and regulatory publishing.
Veeva Vault RIM, eCTD publishing, MS Word, MS Excel, MS PowerPoint, Adobe Acrobat
1mo
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Facilities Regulatory Programs Manager
Gloucester, Massachusetts, United States
$96k-$132k/yr OnsiteFull Time
Bachelor's in engineering or related field (or equivalent experience), knowledge of facility regulatory and safety requirements, experience with inspections/audits in industrial or semiconductor environments, and ability to implement corporate standards.
EHS One, Gensuite
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