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167 regulatory associate jobs at 96 companies in Pennsylvania

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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
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1d
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Associate Director, Regulatory Affairs
United States or Cambridge or Philadelphia
$171k-$231k/yr HybridFull Time
Alnylam Pharmaceuticals
Alnylam PharmaceuticalsNASDAQ: ALNY: Develops RNAi therapeutics to treat rare and common diseases.
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
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1d
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Associate Director, Regulatory Affairs
Cambridge or Philadelphia or Cambridge or Philadelphia or Boston
$171k-$231k/yr HybridFull Time
Alnylam Pharmaceuticals
Alnylam PharmaceuticalsNasdaq: ALNY: Biopharmaceutical developing RNAi medicines.
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
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3mo
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Senior Associate, Regulatory Affairs
Philadelphia or San Francisco
OnsiteFull Time
Dispatch Bio
Dispatch Bio: Develops universal immunotherapy treatments for solid tumor cancers.
2+ YOEBachelor’s in life sciences; 2+ years Regulatory Affairs in biotech/pharma; oncology/IND experience; strong communication; regulatory submissions; FDA/ICH knowledge.
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5d
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(Associate) Director, Regulatory Operations
Philadelphia, Pennsylvania, United States
HybridFull Time
RhyGaze
RhyGaze: Developing optogenetic gene therapies to restore vision in patients.
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
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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
GSK
GSKLondon Stock Exchange: GSK: Develops and manufactures innovative vaccines and specialty medicines.
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.
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Senior Associate, Regulatory Operations
Philadelphia, Pennsylvania, United States
$26-$34/hr HybridTemporary
Publicis Groupe
Publicis GroupeEuronext Paris: PUB: Global communications, advertising, and digital transformation holding.
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
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2w
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QA Associate Technical & Regulatory
Elgin or Fairfield or Arizona or Arkansas or California or Colorado or Connecticut or Florida or Georgia or Hawaii or Illinois or Minnesota or Nevada or New Jersey or New York or Ohio or Pennsylvania or South Carolina or Tennessee or Texas or Washington or Wyoming or Wisconsin
$28-$34/hr RemoteFull Time
Schuman Cheese
Schuman Cheese: Imports, produces, and distributes specialty and Italian-style cheeses.
1+ YOEBachelor's degree preferred in food science, chemistry, biology, or regulatory affairs; 1–3 years in quality assurance, regulatory, or technical manufacturing roles; Microsoft Office proficiency and regulatory knowledge.
Microsoft Office, Microsoft Excel, Microsoft Word, Microsoft Outlook
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1mo
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Associate Director, Regulatory Affairs & Submissions - Nonclinical Development
Laval or Scranton or Columbia or Everett or Montreal
OnsiteFull Time
Altasciences
Altasciences: Provides clinical research and manufacturing services for drug development.
8+ YOE8+ years regulatory affairs experience in nonclinical drug development; PhD/MSc or equivalent; expertise in IND/CTA submissions, GLP/GMP/GCP, global regulatory frameworks; strong medical writing and leadership skills.
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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
Johnson & Johnson
Johnson & JohnsonNYSE: JNJ: Develops and manufactures pharmaceutical drugs and medical devices.
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.
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1w
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Assoc. Dir, Regulatory Affairs-CMC
Rahway or North Wales
$142k-$224k/yr HybridFull Time
Merck & Co.
Merck & Co.NYSE: MRK: Develops and manufactures prescription medicines, vaccines, and animal health products.
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
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Assoc. Dir, Regulatory Affairs-CMC
Rahway or North Wales
$142k-$224k/yr HybridFull Time
Merck & Co.
Merck & Co.NYSE: MRK: Produces prescription medicines, vaccines, and animal health products.
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
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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
Johnson & Johnson
Johnson & JohnsonNYSE: JNJ: Provides pharmaceutical products and medical technology healthcare solutions.
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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2w
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QA Associate Technical & Regulatory
Elgin or Fairfield or Arizona or Arkansas or California or Colorado or Connecticut or Florida or Georgia or Hawaii or Illinois or Minnesota or Nevada or New Jersey or New York or Ohio or Pennsylvania or South Carolina or Tennessee or Texas or Washington or Wyoming or Wisconsin
$28-$34/hr RemoteFull Time
Schuman Cheese: Imports, produces, and distributes specialty cheese products.
1+ YOEBachelor's degree preferred; 1–3 years in quality assurance, regulatory, or technical work in manufacturing or food production; knowledge of FDA, USDA, HACCP, GMP, or FSMA and Microsoft Office proficiency.
FDA, USDA, HACCP, GMP, FSMA, Microsoft Office, Microsoft Excel, Microsoft Word, Microsoft Outlook
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3w
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Food Safety Quality & Regulatory Associate
Hazleton, Pennsylvania, United States
OnsiteFull Time
Cargill
Cargill: Produces and distributes food, agricultural, and industrial products globally.
Bachelor's degree in a related field or equivalent experience. Requires attention to detail, interpersonal and computer skills; SAP, change management, and cross-functional leadership experience preferred.
SAP
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6d
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Mgr Site Regulatory Assurance
Middletown, Pennsylvania, United States
$162k-$180k/yr OnsiteFull Time
Constellation Energy
Constellation EnergyNASDAQ: CEG: Produces carbon-free electricity and supplies energy to customers.
8+ YOERequires a technical bachelor's degree with 8 years' experience, or equivalent SRO, associate degree, or high school pathways with 8–12 years' experience; strong communication and access eligibility required.
Technical Specifications, Updated Final Safety Analysis Reports (UFSAR), Code of Federal Regulations
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2d
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Associate Director GRA CMC SaMD & Cybersecurity Specialist
King of Prussia or Waltham
OnsiteFull Time
CSL
CSLASX: CSL: Develops and manufactures biopharmaceutical products and vaccines.
5+ YOEBachelor’s degree in engineering, computer science, science, or related field; 5+ years of progressive regulatory experience; expertise in global medical device regulations, SaMD, submissions, cybersecurity, and health authority interactions.
Software as a Medical Device (SaMD), Software in a Medical Device (SiMD), Electronic Medical Records (EMR), 510(k), De Novo, PMA, Q-Submission, Pre-Submission, Pre-IND, Pre-BLA, BLA, sBLA, MAA, CTA, IND, DHF, CE, CER, PMCF, IMDRF, ISO 13485, ISO 14971, ISO 10993, ISO 15223, ISO 20916, ISO 18113, ISO 23640, IEC 60601-1, IEC 62304, IEC 62366, IEC/TR 80002-1, EN ISO 14981, AAMI HE75, 21 CFR Part 820, QSR, BIMO, PFSB, MDRMPED, 513(g), IDE, EU MDR 2017/745, EMA, PEI, AGES, PMDA, Health Canada
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1d
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Associate Practice Manager LGH
Lititz or Pennsylvania
FieldFull Time
Penn Medicine
Penn Medicine: Nonprofit academic health system providing hospital care, medical education, biomedical research, and community services.
3+ YOEAssociate's degree preferred with 3+ years of relevant experience; prior healthcare management and front-office supervision experience preferred. Requires regulatory, financial, staffing, and practice operations expertise.
HIPAA, FDA, HCFA, OSHA, CLIA
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1mo
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Associate (Energy)
Frederick or Harrisburg or Lancaster or Pittsburgh or Plymouth Meeting or Radnor or Towson or York
$120k-$200k/yr HybridFull Time
McNees Wallace & Nurick
McNees Wallace & Nurick: Provides comprehensive legal counsel and advocacy services.
3+ YOEJuris Doctor and PA bar admission (or waiver eligibility),3+ years energy law experience (regulatory/utility),litigation preferred,strong writing/analysis,ability to manage matters and complete CLE.
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6d
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Distribution Associate - Akron FirstEnergy Headquarters
Akron or Ohio or Pennsylvania or New York or New Jersey or Maryland or West Virginia
$55k/yr OnsiteFull Time
FirstEnergy
FirstEnergyNYSE: FE: Provides electric power distribution and transmission services to customers.
2+ YOEAssociate degree and 2–3 years of related experience, or high school diploma/GED and 4+ years. Requires 811 regulatory knowledge, ticket-management proficiency, communication, conflict resolution, and Microsoft Office skills.
Microsoft Office Suite, Microsoft Word, Microsoft Excel, Microsoft SharePoint, Microsoft PowerPoint, Gatekeeper NaviGate USA, GIS View
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