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 Pharmaceutical IndustriesNSE: SUNPHARMA: Global specialty generic pharmaceutical headquartered in India.
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: Private biotechnology developing immunotherapy and viral-vector treatments for patients with solid tumors.
2+ YOEBachelor’s in life sciences; 2+ years Regulatory Affairs in biotech/pharma; oncology/IND experience; strong communication; regulatory submissions; FDA/ICH knowledge.
Alnylam PharmaceuticalsNASDAQ: ALNY: Developing RNA interference therapeutics for rare and genetic diseases.
8+ YOEAdvanced degree in a relevant scientific discipline and 8–10 years of pharmaceutical or biotechnology industry experience, including 5+ years in Regulatory Affairs CMC and regulatory submission experience.
RhyGaze: Biotechnology developing gene therapies for patients with blinding retinal diseases.
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 (LSE): GSK: Global biopharmaceutical focused on medicines and vaccines.
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 SquibbNYSE: BMY: Transforming patients' lives through science.
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.
Digitas: Digitas is the Networked Experience Agency, built on the vision that we create magnetic experiences that earn the right for brands to exist in human networks.
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
Bristol Myers SquibbNYSE: BMY: Transforming patients' lives through science.
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.
KardiganNasdaq Global Market: KARD: Clinical-stage biopharmaceutical developing precision medicines targeting cardiovascular disease root causes for patients.
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.
AstraZenecaLondon Stock Exchange: AZN: Global science-led biopharmaceutical.
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.
Johnson & Johnson Innovative MedicineNYSE: JNJ: Johnson & Johnson pharmaceutical organization creating medicines for patients in oncology, immunology, neuroscience and cardiopulmonary care.
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.
MSDNYSE: MRK: We use leading-edge science to save and improve lives.
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
Acadia PharmaceuticalsThe Nasdaq Stock Market LLC: ACAD: Public biopharmaceutical developing and commercializing medicines for underserved neurological and rare disease patients.
8+ YOEBachelor’s degree in life science; 8+ years regulatory drug development; global submissions experience; willing to travel.
Johnson & Johnson Innovative MedicineNYSE: JNJ: Johnson & Johnson pharmaceutical organization creating medicines for patients in oncology, immunology, neuroscience and cardiopulmonary care.
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.
Associate Director, Regulatory Affairs Advertising and Promotion
Bridgewater, New Jersey, United States
$138k-$180k/yrOnsiteFull Time
Recordati Rare Diseases Inc.: Private U.S. pharmaceutical marketing medicines for underserved patients with rare diseases.
8+ YOEBachelor's in a science discipline, 8+ years pharma experience, 4 years direct advertising/promotion review experience, experience submitting regulatory documentation to FDA, Veeva PromoMats and MS Office proficiency.
Veeva PromoMats, Microsoft Outlook, Microsoft Teams, Microsoft Word, Microsoft Excel, Microsoft PowerPoint, eCTD
Tris Pharma: Privately held U.S. biopharmaceutical developing medicines for ADHD, pain, addiction, and central nervous system disorders.
3+ YOERequires a life sciences, pharmacy, or medicine degree; 3–8 years of promotional regulatory review experience depending on level; FDA advertising regulations expertise and direct FDA OPDP experience.
Food and Drug Administration (FDA), Office of Prescription Drug Promotion (OPDP), Form FDA-2253