871 regulatory manager jobs at 335 companies in Gardner, MA
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Innovation Regulatory Manager
Gilsum, New Hampshire, United States
$75k/yr HybridFull Time
5+ YOE5+ years in product development, quality control or regulatory in cosmetics/pharmaceuticals; degree in chemistry/cosmetic science or business; strong regulatory, supplier, and project management experience.
Wrike
1mo
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Regional Regulatory Manager
Billerica, Massachusetts, United States
$104k-$156k/yr HybridFull Time
1+ YOEAdvanced degree such as PhD, PharmD, or MD; at least 1 year of US drug development regulatory strategy experience; FDA interaction experience and matrix leadership skills.
FDA
1mo
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Regional Regulatory Manager
Billerica, Massachusetts, United States
$104k-$156k/yr HybridFull Time
1+ YOEAdvanced degree such as PhD, PharmD, or MD; at least 1 year of US drug development regulatory strategy experience; FDA interaction experience; and demonstrated matrix leadership skills.
FDA
2mo
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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)
15h
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Manager, Regulatory Affairs
Waltham, Massachusetts, United States
$116k-$160k/yr HybridFull Time
6+ YOEBachelor’s degree preferred in a scientific discipline; 6+ years of pharmaceutical experience including 4+ years in Regulatory Affairs; knowledge of U.S. and international drug development requirements and submission experience.
Investigational New Drug (IND), Clinical Trial Application (CTA), New Drug Application (NDA), Standard Operating Procedures (SOP)
1d
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Sr Manager, Regulatory Operations
Newark or Marlborough
$145k-$242k/yr OnsiteFull Time
10+ YOERequires a bachelor's degree and 10+ years of experience, or advanced-degree alternatives. Requires medical device regulatory expertise, FDA, ISO 13485, EU MDD/MDR knowledge, management experience, and strong communication skills.
FURLS, Eudamed, GUDID, ISO 13485, FDA Code of Federal Regulations (21CFR), EU MDD/MDR
1mo
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Senior Manager, Regulatory Accounting
Westlake or Merrimack
OnsiteFull Time
Expertise in mutual fund operations, accounting, or regulatory reporting; knowledge of alternative investments; leadership, stakeholder influence, analytical skills, and InvestOne and Microsoft Office experience.
InvestOne, Microsoft Office
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.
4d
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Senior Manager, Regulatory Operations
Cambridge or United States
$145k-$175k/yr RemoteFull Time
6+ YOEBachelor's degree in life sciences or related field, 6–10 years of biotechnology or pharmaceutical Regulatory Operations experience, FDA electronic submissions, eCTD publishing, Veeva RIM, global submissions, and systems implementation expertise.
Veeva RIM Basics, Veeva Vault RIM, eCTD, AI
2w
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Manager, Regional Regulatory Lead - LCM
Waltham or King of Prussia
$129k-$153k/yr HybridFull Time
5+ YOEBachelor's degree in a relevant life science, 5+ years of biotech or pharmaceutical regulatory experience, 3+ years with developmental products, regional regulatory knowledge, and health authority interaction experience.
Veeva
3w
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Sr Mgr, Regulatory Affairs
Waltham, Massachusetts, United States
$134k-$149k/yr HybridFull Time
6+ YOEBachelor's in life sciences (advanced degree preferred),6+ years biopharma experience (neurology preferred),experience authoring IND/CTA,knowledge of FDA/ICH/eCTD,strong regulatory writing and project management skills.
3mo
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Manger, Transplant Quality & Regulatory Compliance
Boston, Massachusetts, United States
$120k-$150k/yr OnsiteFull Time
5+ YOEBachelor’s degree; 5+ years transplant quality/regulatory experience; CMS/OPTN knowledge; QAPI; certifications preferred.
1mo
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Director, Regulatory Strategist, GRS
Lawrence Township or Cambridge
$215k-$292k/yr OnsiteFull Time
5+ YOEAdvanced scientific degree preferred, significant regulatory affairs experience (senior level), proven global regulatory strategy and HA engagement, strong communication and cross-functional leadership skills.
3mo
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Director, Regulatory Strategy (Pediatrics)
Cambridge, Massachusetts, United States
$184k-$275k/yr HybridFull Time
10+ YOE10+ years in Regulatory Affairs in biopharma; 7+ years pediatric regulatory experience US/EU; lead regulatory submissions and health authority interactions; strong FDA/EMA/ICH knowledge; excellent communication; ability to manage multiple projects.
1mo
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Director, Regulatory Strategist, GRS
Cambridge or Madison or Princeton
$215k-$292k/yr OnsiteFull Time
4+ YOEAdvanced scientific degree preferred, 4+ years regulatory affairs experience, proven global regulatory strategy and HA engagement, leadership of cross-functional teams, strong written/verbal communication and negotiation skills.
2w
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Manager, Regional Regulatory Lead - LCM
Waltham or King of Prussia
$129k-$153k/yr HybridFull Time
5+ YOEBachelor's degree in a life science or related field; 5+ years regulatory or submission experience, 3+ years with developmental products, health authority knowledge, strategic thinking, and strong communication skills.
Veeva, FDA, EMA
2w
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Analyst III, Regulatory Accounting
Gainesville or Downey or Joplin or Londonderry or Merrick or Tahoe Vista or Litchfield Park
$80k-$115k/yr HybridFull Time
5+ YOEBachelor's degree and 5–8 years of accounting or regulatory experience. Requires US GAAP, utility accounting, regulatory reporting, advanced Excel, analytical, communication, and stakeholder management skills.
Microsoft Excel, SAP, Hyperion/HFM, Workiva, Power BI, PowerPlan, BlackLine, FERC Form 1, FERC Form 3-Q, US GAAP, FERC USOA, NARUC
3mo
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Executive Director, Regulatory Affairs
Waltham, Massachusetts, United States
$250k-$310k/yr OnsiteFull Time
18+ YOESenior regulatory leader with 18+ years in regulatory affairs, 10+ in management; strong FDA/EMA knowledge; CTD experience; regulatory filings leadership.
1mo
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Regulatory Specialist, Beauty & Wellness
Marlborough, Massachusetts, United States
$70k-$88k/yr HybridFull Time
2+ YOEHigh school degree; 5+ years consumer-relations complaint handling or 2+ years regulatory adverse event reporting; familiarity with FDA/CPSC/MDR reporting, complaint management, SOPs, and audits; authorized to work in the U.S.
2mo
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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.
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