180 regulatory associate jobs at 86 companies in Bethlehem, PA

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
2d
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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
1w
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Associate, Regulatory Affairs- Labeling
Princeton or Hawthorne or New Jersey
$95k-$105k/yr OnsiteFull Time
Sun Pharma
Sun PharmaNSE: SUNPHARMA: Develops and manufactures generic and specialty pharmaceutical products worldwide.
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
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.
3mo
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Associate Director, Regulatory CMC
Palo Alto or Princeton or Miami
$194k-$199k/yr HybridFull Time
Summit Therapeutics
Summit TherapeuticsNASDAQ: SMMT: Developing oncology therapies to improve patient quality of life.
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
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
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.
2mo
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Associate Director Global Regulatory Sciences - Oncology
Princeton or Cambridge
$173k-$210k/yr OnsiteFull Time
Bristol Myers Squibb
Bristol Myers SquibbNew York Stock Exchange: BMY: Develops and distributes innovative medicines for serious diseases.
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.
2mo
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Associate Director, Regulatory Affairs - CMC
Warren, New Jersey, United States
$169k-$213k/yr HybridFull Time
PTC Therapeutics
PTC TherapeuticsNASDAQ: PTCT: Develops and commercializes treatments for patients with rare diseases
7+ YOEBachelor's in science, 7+ years regulatory affairs/CMC writing experience in pharma/biotech, small-molecule CMC expertise, GMP knowledge, ICH/regulatory guidance familiarity, Microsoft Office proficiency, up to 10% travel.
Microsoft Office, eCTD
1mo
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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
2mo
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Associate Director, Regulatory Strategy
South San Francisco or Princeton
$170k-$230k/yr HybridFull Time
Kardigan
Kardigan: Developing precision medicines to treat and cure cardiovascular disease.
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
1mo
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Associate Director, Commercial Regulatory Affairs
Princeton, New Jersey, United States
$173k-$210k/yr OnsiteFull Time
Bristol Myers Squibb
Bristol Myers SquibbNYSE: BMY: Develops and manufactures innovative prescription biopharmaceutical medicines.
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.
2mo
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Associate Director, Regulatory Affairs - Biosimilars (US)
Princeton, New Jersey, United States
$146k-$279k/yr HybridFull Time
Sandoz
SandozSIX Swiss Exchange: SDZ: Develops and manufactures generic medicines and biosimilar treatments.
7+ YOE7+ years regulatory affairs in biopharma with US biosimilar experience; FDA submissions; strong cross-functional leadership and communication.
1mo
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Associate Manager, Regulatory Advertising & Promotion
Sleepy Hollow or Warren
$110k-$179k/yr HybridFull Time
Regeneron
RegeneronNasdaq: REGN: Discovers and manufactures medicines for serious diseases.
1+ YOE1–2 years regulatory affairs experience (advertising & promotion preferred),BS required; advanced scientific degree preferred; knowledge of advertising/promotion regulations; experience interacting with FDA OPDP; strong written/verbal skills.
1mo
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Associate Manager, Regulatory Affairs Strategy - Oncology
Tarrytown or Warren
$110k-$179k/yr HybridFull Time
Regeneron Pharmaceuticals
Regeneron PharmaceuticalsNASDAQ: REGN: Discovers and develops medicines for serious diseases.
2+ YOEBachelor's degree required (advanced degree preferred), minimum 2 years pharma regulatory experience (oncology preferred), knowledge of US FDA and international regulations, CRO interaction experience, strong written and verbal English.
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.
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
3mo
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Associate Director, Regulatory Affairs Project Planning & Coordination
Princeton or San Diego or San Francisco
$154k-$193k/yr HybridFull Time
Acadia Pharmaceuticals
Acadia PharmaceuticalsNASDAQ: ACAD: Develops and sells medicines for neurological and rare diseases.
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
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
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.