74 regulatory associate jobs at 51 companies in West Warwick, RI
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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: Private British payments and foreign-exchange firm serving businesses, financial institutions, and individuals worldwide.
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
Viridian TherapeuticsThe Nasdaq Stock Market LLC: VRDN: Public biotechnology developing and commercializing antibody medicines for patients with autoimmune and rare diseases.
10+ YOE10+ years Regulatory Affairs in biopharma; BS in science; experience with INDs/CTAs/NDAs/MAAs; strong regulatory strategy and communication.
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.
Kailera TherapeuticsNasdaq Global Select Market: KLRA: Clinical-stage biopharmaceutical developing 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%.
Oruka TherapeuticsNASDAQ: ORKA: Developing novel biologic antibodies for people with psoriasis and other 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: Biotechnology focused on mRNA-based medicine and vaccine development.
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: Non-profit cancer research and treatment center.
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)
Associate Director, Regulatory Advertising and Promotion
Waltham, Massachusetts, United States
$185k-$197k/yrHybridFull Time
AlkermesNasdaq: ALKS: Public Irish biopharmaceutical developing and commercializing neuroscience medicines for people with 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.
Senior Living Residences: Private U.S. senior-living management operating independent living, assisted living, and memory-care communities for older adults.
3+ YOEAssociate's degree and strong organizational, project management, communication, technology, and judgment skills required. Three years of relevant experience and regulated healthcare experience preferred; travel may be required.
Microsoft Office, Google Workspace, OSHA, HIPAA, Medicaid
AbbVieNYSE: ABBV: Global biopharmaceutical discovering and delivering innovative medicines.
8+ YOE3+ MgmtBachelor's degree in a relevant field and 8 years of pharmaceutical experience, including 3 years of leadership. Requires regulatory strategy, health authority, communication, and matrix-environment experience.
Fresenius Medical CareFrankfurt Stock Exchange, NYSE: FME, FMS: Global provider of dialysis products and renal healthcare services.
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.
Associate Director GRA CMC SaMD & Cybersecurity Specialist
King of Prussia or Waltham
OnsiteFull Time
CSL Behring: Global biotherapeutics leader driven by our promise to save lives.
5+ YOEBachelor’s degree in engineering, computer science, science, or related field; 5+ years of progressive regulatory experience; expertise in global medical device regulations, SaMD, submissions, cybersecurity, and health authority interactions.
Software as a Medical Device (SaMD), Software in a Medical Device (SiMD), Electronic Medical Records (EMR), 510(k), De Novo, PMA, Q-Submission, Pre-Submission, Pre-IND, Pre-BLA, BLA, sBLA, MAA, CTA, IND, DHF, CE, CER, PMCF, IMDRF, ISO 13485, ISO 14971, ISO 10993, ISO 15223, ISO 20916, ISO 18113, ISO 23640, IEC 60601-1, IEC 62304, IEC 62366, IEC/TR 80002-1, EN ISO 14981, AAMI HE75, 21 CFR Part 820, QSR, BIMO, PFSB, MDRMPED, 513(g), IDE, EU MDR 2017/745, EMA, PEI, AGES, PMDA, Health Canada
Hebrew SeniorLife: Senior healthcare and housing provider.
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.
Microbac Laboratories: Family-owned commercial testing laboratory serving businesses, organizations, and agencies across environmental, food, life sciences, and specialty testing.
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.
EversourceNYSE: ES: New England's largest energy delivery system.
0+ YOEBachelor’s degree in engineering, computer science, or related field, or equivalent education and experience; 0–3 years of related experience; analytical, communication, database, and regulatory reporting skills preferred.
Microsoft Excel, Microsoft Word, Microsoft PowerPoint, Archer, Compliance Universe
Tonix PharmaceuticalsNASDAQ: TNXP: Publicly traded biopharmaceutical developing and commercializing CNS, immunology, infectious-disease, and rare-disease therapies.
5+ YOEBachelor’s degree in science or related discipline or equivalent experience, plus 5+ years of supplier quality experience in biotechnology or pharmaceuticals. Requires GxP, GMP, regulatory, auditing, and communication skills.
Deciphera Pharmaceuticals: Commercial-stage biopharmaceutical developing kinase medicines for people living with cancer.
3+ YOEBachelor’s or Master’s degree and at least 3 years of clinical operations experience in pharmaceutical or CRO settings. Requires ICH, GCP, regulatory, organizational, problem-solving, and trial management skills.
Care New England: Integrated health care organization based in Rhode Island.
3+ YOEJuris Doctor and active bar admission required; 3+ years legal experience preferred with healthcare, employment, litigation, contracts, privacy, and regulatory experience.
Sunnyside: Private cannabis dispensary brand offering adult-use and medical cannabis, online ordering, education, and in-store pickup across U.S. markets.
1+ YOEHigh school diploma or equivalent, at least 1 year of customer service experience, strong customer engagement skills, regulatory compliance, and ability to lift up to 50 pounds or 100 pounds with assistance.
Point of Sale, Standard Operating Procedures (SOPs)