97 regulatory associate jobs at 70 companies in Putnam, CT
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Regulatory Reporting Associate
Stamford or Orlando or Providence or Toronto or United States or Canada or North America
$90k/yrHybridFull Time
Moneycorp: Provides global money transfer and foreign exchange services.
3+ YOE3+ years in regulatory/compliance/risk functions, working knowledge of regulatory frameworks, strong analytical and stakeholder skills, ability to interpret regulations, and proficiency with Microsoft Office (Excel, Word, PowerPoint).
Microsoft Office, Microsoft Excel, Microsoft Word, Microsoft PowerPoint
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.
Kailera Therapeutics: Developing clinical-stage injectable and oral therapies for obesity.
5+ YOEPrepare and lead regulatory submissions (IND/CTA/NDAs/MAAs), provide regulatory strategy and guidance, monitor global regulations, and support cross-functional teams; travel ~10-15%.
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.
Oruka TherapeuticsNASDAQ: ORKA: Develops long-acting biologics for chronic skin and inflammatory diseases.
6+ YOEMaster's or PhD in life sciences, 6+ years CMC experience with minimum 3+ years regulatory CMC in biologics, cGMP and global regulatory submission expertise (FDA/EMA/ICH), experience authoring Module 3 and combination product submissions.
ModernaNasdaq: MRNA: Develops and manufactures messenger RNA medicines and vaccines.
8+ YOEBS/MS/PhD in molecular biology, pharmaceutics, chemistry, chemical engineering or related field; 8+ years pharma/biotech experience; 5+ years regulatory CMC experience; strong knowledge of global CMC regulations and CTD format.
Boston or Brookline or Maine or Vermont or New Hampshire or Massachusetts or Connecticut or Rhode Island
$56k-$62k/yrRemoteFull Time
Dana-Farber Cancer Institute: Provides comprehensive cancer treatment and conducts oncological research.
0+ YOEBachelor's degree or one year as an associate regulatory coordinator; strong communication, organization, computer, database, medical terminology, and basic clinical trial knowledge preferred.
Microsoft applications, databases, Food and Drug Administration (FDA), Institutional Review Board (IRB), Investigational New Drug (IND), Investigational Device Exemption (IDE)
AbbVieNYSE: ABBV: Develops and sells innovative pharmaceutical and biopharmaceutical medicines.
4+ YOEBA/BS in chemical, biological sciences, or related field; 4 years of pharmaceutical or related experience; 1–2 years in quality systems or cross-functional project management; regulatory affairs experience preferred.
electronic document management systems, regulatory business systems, CTD
Swiss ReSIX Swiss Exchange: SREN: Provides global reinsurance and insurance-based risk management solutions.
2+ YOE2+ years insurance regulatory experience preferred; advanced Microsoft Word/Excel proficiency; familiarity with filing platforms and bureau circulars; strong communication and project-management skills.
Microsoft Word, Microsoft Excel, SERFF, iFile, NILS, ISOnet, Microsoft PowerPoint, Microsoft Outlook, Microsoft SharePoint
Associate Director, Regulatory Advertising and Promotion
Waltham, Massachusetts, United States
$185k-$197k/yrHybridFull Time
AlkermesNASDAQ: ALKS: Develops medicines for psychiatric and neurological disorders.
7+ YOEBachelor's degree in health or science,7+ years regulatory advertising and promotion review experience,applied knowledge of FDA laws/guidance,clinical trial understanding,strong communication and interpersonal skills,ability to advise stakeholders;travel up to 20% preferred.
Fresenius Medical CareNew York Stock Exchange: FMS: Provides dialysis services and manufactures renal care medical devices
8+ YOEBachelor's degree required (advanced degree preferred), minimum 8 years submission experience including prior 510(k) work, knowledge of U.S. and international device regulations, project management, and strong written/verbal skills.
Nassau Financial Group: Provides life insurance, annuity products, and asset management services.
2+ YOEJuris Doctor and Connecticut bar admission required, minimum 2 years' practical legal experience; litigation, insurance/regulatory experience preferred; strong legal research, writing, and communication skills.
Hebrew SeniorLife: Provides comprehensive senior living and geriatric healthcare services.
1+ YOEHigh school diploma or equivalent, food handler certification (or obtain within 6 months), customer service and food service experience in healthcare preferred, able to follow Kosher and regulatory food safety requirements.
Boston College: Private Jesuit research university providing undergraduate and graduate degrees.
5+ YOEBachelor's required (Master's preferred),5+ years building/administering production research or program databases, hands-on Quickbase and relational modeling, SQL and Python/R, experience with sensitive/regulatory data.
Microbac Laboratories: Provides laboratory testing services for food and environmental safety
Client service experience preferred; strong communication, organization, project coordination, troubleshooting, delegation, and collaboration skills; familiarity with FDA and EPA regulatory testing requirements.
Must be 21+, high school diploma/GED, exceptional customer service, basic computer and POS skills, retail experience preferred, must comply with cannabis regulatory requirements.
NEFCO: Distributes construction supplies and provides support services to contractors.
Provide administrative support for driver onboarding, maintain Driver Qualification Files, manage regulatory recordkeeping, and assist with driver and vehicle compliance per DOT/FMCSA; strong organizational and communication skills required.
Microsoft Office Suite, Geotab, Foley, DQF, Best Pass
Deciphera Pharmaceuticals: Developing targeted kinase inhibitors for the treatment of cancer.
3+ YOEBachelor’s or Master’s degree, 3+ years of pharmaceutical or CRO clinical operations experience, knowledge of ICH, GCP, and regulatory requirements, plus strong organizational and problem-solving skills.
Care New England Health System: Integrated non-profit health system providing hospital and medical services.
3+ YOEJuris Doctor and active bar admission required; 3+ years legal experience preferred with healthcare, employment, litigation, contracts, privacy, and regulatory experience.