1,446 regulatory manager jobs at 535 companies in Marblehead, MA
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Regulatory Affairs Manager
Lowell, Massachusetts, United States
$105k-$125k/yrOnsiteFull Time
Tri-Imaging Solutions: Provider of medical imaging parts, repair, and technical training.
3+ YOE2+ MgmtBachelor's in Food Science or related field, 3+ years in food manufacturing or regulatory work, 2+ years managing food labeling and regulatory documentation, and supervisory experience.
Microsoft Office, ERP systems, nutrition analysis/compliance software
Merck KGaA, Darmstadt, GermanyFrankfurt Stock Exchange: MRK: A science and technology in healthcare, life sciences, and electronics.
1+ YOEAdvanced degree such as PhD, PharmD, or MD; at least 1 year of US drug development regulatory strategy experience; FDA interaction experience and matrix leadership skills.
Merck KGaAFrankfurt Stock Exchange: MRK: Develops pharmaceutical, life science, and electronics technologies.
1+ YOEAdvanced degree such as PhD, PharmD, or MD; at least 1 year of US drug development regulatory strategy experience; FDA interaction experience; and demonstrated matrix leadership skills.
San Francisco or Salt Lake City or Phoenix or Los Angeles or Chicago or Boston or Austin or New York City or Miami or Tampa or Atlanta or Columbus or Boise or San Diego or Minneapolis or Houston or Raleigh or Nashville or Kansas City or Charlotte or Portland or Philadelphia or Dallas or Washington or Seattle
$173k-$223k/yrRemoteFull Time
CircleNYSE: CRCL: Digital currency issuer and blockchain financial infrastructure provider.
10+ YOERequires 10+ years in financial institution compliance or regulatory work, compliance program implementation, regulatory change management, regulatory analysis, cross-functional leadership, and familiarity with Slack, Apple MacOS, and GSuite.
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.
New York City or Boston or Dallas or Miami or Chicago or San Francisco or Los Angeles
$110k-$135k/yrHybridFull Time
Stable Rock: Provides integrated financial and operational back-office outsourcing for businesses.
4+ YOERequires a bachelor's degree in a business-related field and 4+ years of investment adviser compliance experience, plus regulatory knowledge, analytical skills, communication, and Microsoft Office proficiency.
Fidelity Investments: Provides investment management, retirement planning, and brokerage services.
Expertise in mutual fund operations, accounting, or regulatory reporting; knowledge of alternative investments; leadership, stakeholder influence, analytical skills, and InvestOne and Microsoft Office experience.
MerckXETRA: MRK: A science and technology providing healthcare, life science, and electronics solutions.
1+ YOEBachelor's in life science, 1+ years pharmaceutical or regulatory/CMC experience; experience preparing CMC dossiers, regulatory strategy, and health authority interactions; strong writing and communication skills.
Los Angeles or Atlanta or Cincinnati or Milwaukee or New York or Minneapolis or Chicago or Boston or Philadelphia or Denver or Charlotte
$139k-$164k/yrHybridFull Time
U.S. BankNYSE: USB: Provider of personal, business, and institutional financial services.
8+ YOELaw degree and license to practice in jurisdiction, 8+ years related experience, knowledge of the Investment Company Act of 1940, ability to manage teams and complex projects, strong communication and regulatory drafting skills.
Avalyn Pharma: Develops inhaled therapies for rare respiratory diseases.
5+ YOEBachelor’s degree and 5–8+ years of regulatory affairs experience in pharmaceutical, biotechnology, or combination products. Requires global submissions, FDA interactions, clinical development, eCTD, ICH, and strong cross-functional skills.
Waukegan or Hazelwood or Dublin or Illinois or Mansfield
$105k-$150k/yrHybridFull Time
Cardinal HealthNYSE: CAH: Distributes pharmaceuticals and manufactures medical products for healthcare providers.
7+ YOEBachelor's in science/engineering/life sciences required, 7+ years regulatory affairs medical device labeling experience, RAC preferred; deep knowledge of global device and environmental labeling regulations; strong attention to detail and project leadership.
Parabilis Medicines: Developing helical peptide therapeutics for undruggable cancer targets.
6+ YOEBachelor's degree in life sciences or related field, 6–10 years of biotechnology or pharmaceutical Regulatory Operations experience, FDA electronic submissions, eCTD publishing, Veeva RIM, global submissions, and systems implementation expertise.
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.
Director, Regulatory Strategy – Global Regulatory Lead
Boston, Massachusetts, United States
$212k-$259k/yrHybridFull Time
Beeline Medicines: A clinical-stage biotechnology focused on precision therapies for autoimmune diseases.
10+ YOE5+ MgmtAdvanced life sciences degree; 10+ years regulatory affairs; global regulatory leadership; experience with FDA/EMA; immunology/autoimmune knowledge.
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.
Verily: Developing data-driven technologies for clinical research and precision health.
5+ YOEBachelors in a quantitative field and 5+ years regulatory affairs experience in medical device/digital health; expertise in SaMD/AI/ML compliance, FDA guidance, ISO 13485, risk management, and statistical evaluation; proficiency with Jira, GitHub, and Google Workspace.
Jira, GitHub, Google Workspace, document control systems, Python, R, Claude, ChatGPT
Senior Manager, Regulatory Data Analytics & Reporting
Londonderry, New Hampshire, United States
OnsiteFull Time
LibertyNYSE: AQN: Provides regulated electricity, water, and natural gas utility services.
10+ YOELeads data enablement and reporting strategy for regulatory analysis; requires Bachelor's degree, 10+ years progressive experience (utility/regulatory preferred), expertise in data modeling, analytics, visualization (SQL, Python, R, Tableau, Power BI), and strong project management.