176 regulatory associate jobs at 80 companies in Limerick, PA
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Regulatory Associate
Lancaster, Pennsylvania, United States
OnsiteFull Time
Shank's Extracts: Manufactures food extracts, flavorings, and coloring for global distribution.
1+ YOESupport regulatory compliance, maintain supplier and product documentation, assist with audits and regulatory research; bachelor’s degree or equivalent and QA experience preferred; PA driver’s license required.
Microsoft Excel, Microsoft Word, ERP
1d
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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
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
1w
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Associate, Regulatory Affairs- Labeling
Princeton or Hawthorne or New Jersey
$95k-$105k/yr OnsiteFull Time
1+ YOEBachelor's degree in a scientific field, 1–3 years of generic pharmaceutical regulatory experience, advanced computer skills, strong writing and communication skills, and ability to work independently.
Artwork Management System (AMS), FDA, SPL, ANDA
3mo
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Senior Associate, Regulatory Affairs
Philadelphia or San Francisco
OnsiteFull Time
2+ YOEBachelor’s in life sciences; 2+ years Regulatory Affairs in biotech/pharma; oncology/IND experience; strong communication; regulatory submissions; FDA/ICH knowledge.
3mo
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Associate Director, Regulatory CMC
Palo Alto or Princeton or Miami
$194k-$199k/yr HybridFull Time
6+ YOEBachelor’s degree in chemistry, pharmacy, engineering, or biochemistry; 6+ years Regulatory CMC experience; experience with biologics; strong FDA/EU regulatory knowledge; experience preparing CMC submissions (IND/IMPD/BLA/MAA). Mandarin desirable.
Microsoft Word, Microsoft Excel, Document management systems
6d
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(Associate) Director, Regulatory Operations
Philadelphia, Pennsylvania, United States
HybridFull Time
8+ YOERequires 8+ years in Regulatory Operations, global submission planning, eCTD and ICH expertise, regulatory or document management systems experience, vendor management, and ability to build processes independently.
Veeva RIM Basics, ZenQMS, eCTD, ICH, FDA, EMA, MHRA, Health Canada
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.
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.
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Senior Associate, Regulatory Operations
Philadelphia, Pennsylvania, United States
$26-$34/hr HybridTemporary
2+ YOEBachelor's degree and 2+ years preparing complex submission deliverables; strong Adobe Acrobat and Microsoft Office skills, attention to detail, organization, and clear technical writing.
Adobe Acrobat, Microsoft Office Suite, Adobe InDesign, Adobe Photoshop
2mo
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Associate Director, Regulatory Strategy
South San Francisco or Princeton
$170k-$230k/yr HybridFull Time
6+ YOEBachelor's in life sciences required; 6+ years regulatory affairs experience in biotech/pharma; experience with INDs/CTAs and eCTD submissions; knowledge of FDA/EMA/ICH guidance; strong communication and organizational skills.
eCTD
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Associate Director, Commercial Regulatory Affairs
Princeton, New Jersey, United States
$173k-$210k/yr OnsiteFull Time
3+ YOEBS required (advanced degree preferred); 3-5 years regulatory promotional review or 5-8 years pharma experience; experience with promotional risk assessment and OPDP interactions; strong communication and analytical skills.
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Associate Director, Promotional Regulatory Affairs
Gaithersburg or Wilmington
$150k-$225k/yr HybridFull Time
5+ YOE5+ years regulatory affairs experience in pharma/biotech, working knowledge of FDA promotional regulations, Bachelors in pharmacy/life sciences preferred, experience with electronic review tools and VEEVA PromoMats.
VEEVA PromoMats
2mo
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Associate Director, Regulatory Affairs - Biosimilars (US)
Princeton, New Jersey, United States
$146k-$279k/yr HybridFull Time
7+ YOE7+ years regulatory affairs in biopharma with US biosimilar experience; FDA submissions; strong cross-functional leadership and communication.
1w
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Research Regulatory Coordinator, Full Time,
Moorestown or Voorhees or Marlton
$26-$39/hr HybridFull Time
3+ YOERequires 3+ years supporting clinical research regulatory activities, IRB applications, investigator documentation, and protocol approvals; strong organization and communication skills; associate degree required, bachelor's preferred.
Institutional Review Board (IRB), FDA 1572, Virtua
2mo
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Associate Director, Regulatory Affairs Labeling Product Leader
Raritan or Horsham or Titusville or Spring House
$137k-$236k/yr HybridFull Time
8+ YOEBachelor's in a scientific discipline required; advanced degree preferred. Minimum 8 years' professional experience and 6 years' direct regulatory labeling content experience. Pharmaceutical regulatory experience, document management system experience, strong communication and leadership in matrix teams.
1w
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Assoc. Dir, Regulatory Affairs-CMC
Rahway or North Wales
$142k-$224k/yr HybridFull Time
5+ YOEBachelor's degree or equivalent required; 5+ years in pharmaceutical or biotech Regulatory CMC, digital tools, automation, AI/LLM, change management, mentoring, and cross-functional project leadership.
Artificial Intelligence (AI), machine learning, Veeva, ERA App, Electronic Common Technical Document (eCTD), AI/LLM
3mo
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Associate Director, Regulatory Affairs Project Planning & Coordination
Princeton or San Diego or San Francisco
$154k-$193k/yr HybridFull Time
8+ YOEBachelor’s degree in life science; 8+ years regulatory drug development; global submissions experience; willing to travel.
1w
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Assoc. Dir, Regulatory Affairs-CMC
Rahway or North Wales
$142k-$224k/yr HybridFull Time
5+ YOEBS or equivalent scientific, technical, or regulatory degree; 5+ years in pharmaceutical or biotech Regulatory CMC; hands-on digital, automation, and AI/LLM experience; change management, mentoring, collaboration, and project coordination skills.
Artificial Intelligence (AI), machine learning, generative AI, AI/LLM, Electronic Common Technical Document (eCTD), Veeva, ERA App
2mo
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Associate Director, Regulatory Affairs Labeling Product Leader
Raritan or Horsham or Titusville or Spring House
$137k-$236k/yr HybridFull Time
8+ YOEBachelor's in a scientific discipline, 8+ years professional experience, 6+ years direct regulatory labeling experience, pharma regulatory knowledge, target labeling/NME experience preferred, strong communication and leadership skills.
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