Leeds or Raynham or Palm Beach Gardens or Warsaw or Raritan or Ringaskiddy
HybridFull Time
Johnson & JohnsonNYSE: JNJ: Develops and manufactures pharmaceutical drugs and medical devices.
6+ YOEBachelor’s degree and 6–8 years in Quality, Regulatory Affairs, or Standards Compliance in a regulated industry. Requires regulatory interpretation, QMS knowledge, audit support, cross-functional influence, and strong communication.
Kymera TherapeuticsNASDAQ: KYMR: Develops targeted protein degradation medicines to treat human diseases.
5+ YOE5+ years regulatory affairs drug development experience managing INDs/CTAs and designation requests; experience with EU CTR/CTIS; Bachelor’s degree in a scientific discipline required; strong regulatory writing, communication and cross-functional collaboration skills.
Clinical Trials Information System (CTIS), EU Clinical Trials Regulation (EU CTR)
Deciphera Pharmaceuticals: Developing targeted kinase inhibitors for the treatment of cancer.
6+ YOEBachelor’s degree preferred in a scientific discipline; 6+ years of pharmaceutical industry experience, including 4+ years in Regulatory Affairs; knowledge of U.S. and international drug regulations.
HologicNASDAQ: HOLX: Develops medical technology for women's healthcare and diagnostics.
10+ YOERequires a bachelor's degree and 10+ years of experience, or advanced-degree alternatives. Requires medical device regulatory expertise, FDA, ISO 13485, EU MDD/MDR knowledge, management experience, and strong communication skills.
FURLS, Eudamed, GUDID, ISO 13485, FDA Code of Federal Regulations (21CFR), EU MDD/MDR
CSLASX: CSL: Develops and manufactures biopharmaceutical products and vaccines.
5+ YOEBachelor's degree in a relevant life science, 5+ years of biotech or pharmaceutical regulatory experience, 3+ years with developmental products, regional regulatory knowledge, and health authority interaction experience.
AlkermesNASDAQ: ALKS: Develops medicines for psychiatric and neurological disorders.
6+ YOEBachelor's in life sciences (advanced degree preferred),6+ years biopharma experience (neurology preferred),experience authoring IND/CTA,knowledge of FDA/ICH/eCTD,strong regulatory writing and project management skills.
Moneycorp: Provides global money transfer and foreign exchange services.
3+ YOE2+ MgmtOver 3 years in money transmitter licensing compliance, 5+ years in NMLS, 2+ years in management; strong knowledge of licensing regulations; English proficiency.
CSLASX: CSL: Global biotechnology producing plasma-derived and recombinant therapies.
5+ YOEBachelor's degree in a life science or related field; 5+ years regulatory or submission experience, 3+ years with developmental products, health authority knowledge, strategic thinking, and strong communication skills.
Helen of TroyNASDAQ: HELE: Designs and markets branded consumer housewares and personal care products.
2+ YOEHigh school degree; 5+ years consumer-relations complaint handling or 2+ years regulatory adverse event reporting; familiarity with FDA/CPSC/MDR reporting, complaint management, SOPs, and audits; authorized to work in the U.S.
Cardinal HealthNYSE: CAH: Distributes pharmaceuticals and manufactures medical products for healthcare providers.
5+ YOE5+ years of regulatory affairs experience preferred, scientific bachelor's degree preferred, medical device experience a plus, STED and FDA medical device regulatory proficiency, project management, communication, and travel capability.
Treeline Biosciences: Develops precision medicines for cancer and serious diseases.
8+ YOEAdvanced regulatory affairs leader with 8+ years in biopharma, experience with FDA/EMA/ICH, IND/NDA/BLA submissions, agency interactions, project management, and oncology preferred.
Stoke TherapeuticsNASDAQ: STOK: Develops RNA-based therapies for severe genetic disorders.
8+ YOERequires 8+ years of pharmaceutical Regulatory Affairs experience, major regulatory submission expertise, regulatory authority interaction experience, strong communication and negotiation skills, analytical problem-solving, and ability to manage senior personnel.
TANGO, RNA, antisense oligonucleotides (ASOs), Employee Stock Purchase Program (ESPP)
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.
Project Manager - Regulatory, Audit and Compliance
Canton, Massachusetts, United States
$81k-$172k/yrHybridFull Time
CGINYSE: GIB: Provides information technology and business consulting services.
10+ YOERequires 10+ years of project or program management, process management and health insurance operations experience, healthcare payer regulatory expertise, strong stakeholder skills, and a bachelor's degree or equivalent experience.
Noema Pharma: Developing innovative therapies for neurological and central nervous system disorders.
10+ YOERequires a life sciences bachelor's degree, 10+ years of pharmaceutical regulatory experience, multinational development experience, CTD familiarity, FDA and international regulatory knowledge, leadership, communication, and project management skills.
Acrivon TherapeuticsNasdaq: ACRV: Develops precision oncology medicines using a proteomics-based platform.
15+ YOEDoctorate-level scientific degree required; 15+ years (VP) or 20+ years (SVP) regulatory affairs experience in biotech/pharma with oncology, INDs/global development, health authority interactions, and executive leadership.
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