180 regulatory associate jobs at 86 companies in Bethlehem, PA
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Associate Director, Regulatory Affairs
United States or Cambridge or Philadelphia
$171k-$231k/yrHybridFull Time
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
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
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.
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.
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
Upper Providence or Waltham or Rockville or Durham or Cambridge or San Francisco
$139k-$231k/yrHybridFull Time
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.
Associate Director Global Regulatory Sciences - Oncology
Princeton or Cambridge
$173k-$210k/yrOnsiteFull Time
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.
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.
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
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.
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.
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.
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.
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
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
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.