1,445 regulatory manager jobs at 542 companies in Lowell, MA
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Innovation Regulatory Manager
Gilsum, New Hampshire, United States
$75k/yrHybridFull Time
W.S. Badger Company: Manufacturer of organic skincare and personal care products.
5+ YOE5+ years in product development, quality control or regulatory in cosmetics/pharmaceuticals; degree in chemistry/cosmetic science or business; strong regulatory, supplier, and project management experience.
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.
Tri-Imaging Solutions: Provider of medical imaging parts, repair, and technical training.
3+ YOEBachelor's in Food Science (Master's preferred),3+ years food manufacturing/regulatory/QA experience,2+ years managing labeling and regulatory documentation,leadership experience,knowledge of FDA/USDA/HACCP/SQF,Microsoft Office and ERP proficiency.
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.
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.
Applied MaterialsNASDAQ: AMAT: Produces equipment and services for chip and display manufacturing.
Bachelor's in engineering or related field (or equivalent experience); working knowledge of facility regulatory and safety requirements; experience with inspections, audits, corrective actions in manufacturing/industrial settings; familiarity with EHS compliance platforms.
Johnson & JohnsonNYSE: JNJ: Develops and manufactures pharmaceutical drugs and medical devices.
8+ YOE2+ MgmtBachelor's degree in science or quality engineering, 8+ years of related experience including 2–3 years in management or supervision, strong compliance, audit, communication, collaboration, and influence skills.
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.
Oruka TherapeuticsNASDAQ: ORKA: Develops long-acting biologics for chronic skin and inflammatory diseases.
8+ YOEBachelor's in life sciences required, advanced degree preferred. RAC a plus. 8+ years regulatory affairs experience in biotech/pharma with IND/CTA and global submissions, FDA interactions, and strong regulatory planning skills.
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.