1,488 regulatory manager jobs at 550 companies in Sharon, MA
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Regional Regulatory Manager
Billerica, Massachusetts, United States
$104k-$156k/yrHybridFull Time
EMD Serono: Private biopharmaceutical business developing medicines and patient-support services for people with infertility, multiple sclerosis, and cancer.
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.
EMD Serono: Private biopharmaceutical business developing medicines and patient-support services for people with infertility, multiple sclerosis, and cancer.
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.
FlywireNasdaq Global Select Market: FLYW: Public global payments and software helping education, healthcare, travel, and B2B organizations collect complex payments.
Manage multi-state money transmitter reporting and licensing, regulatory filings, compliance audits, reconciliation controls, dashboards, policies, and regulator relationships.
NetSuite, Looker, Microsoft Excel, NMLS Database, GAAP, FinCEN, MTMA
Collegium PharmaceuticalNASDAQ: COLL: Public U.S. biopharmaceutical developing and commercializing ADHD and responsible pain medicines for people with serious conditions.
4+ YOEBachelor's required (Master's preferred),4+ years pharma/life sciences experience,strong regulatory knowledge,experience with document management and electronic publishing,Microsoft Office proficiency,excellent communication.
Microsoft Excel, Microsoft Outlook, Microsoft PowerPoint, Microsoft Word
Leeds or Raynham or Palm Beach Gardens or Warsaw or Raritan or Ringaskiddy
HybridFull Time
DePuy Synthes: ’s private orthopaedic medical-technology business supplies surgeons and healthcare systems worldwide.
6+ YOEBachelor’s degree and 6–8 years in Quality, Regulatory Affairs, or Standards Compliance in a regulated industry. Requires regulatory interpretation, QMS expertise, cross-functional influence, audit support, and analytical skills.
ISO 13485, ISO 14971, IEC, FDA QSR, EU MDR, Quality Management Systems (QMS)
Leeds or Raynham or Palm Beach Gardens or Warsaw or Raritan or Ringaskiddy
HybridFull Time
DePuy Synthes: ’s private orthopaedic medical-technology business supplies surgeons and healthcare systems worldwide.
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.
Acushnet Company: Private American golf-equipment and golf-wear manufacturer serving dedicated and recreational golfers worldwide.
8+ YOEBachelor's degree and 8+ years in product compliance/regulatory affairs; knowledge of global regulations (REACH, RoHS, CPSIA, Proposition 65, WEEE); strong analytical, communication, and stakeholder management skills.
Kymera TherapeuticsNasdaq: KYMR: Clinical-stage biotechnology developing oral small-molecule degrader medicines for immunological and oncology 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: Commercial-stage biopharmaceutical developing kinase medicines for people living with cancer.
6+ YOEBachelor’s degree preferred in a scientific discipline; 6+ years of pharmaceutical experience including 4+ years in Regulatory Affairs; knowledge of U.S. and international drug development requirements and submission experience.
Investigational New Drug (IND), Clinical Trial Application (CTA), New Drug Application (NDA), Standard Operating Procedures (SOP)
HologicNasdaq: HOLX: Developing medical technology focused on women's health.
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
New York City or Boston or Dallas or Miami or Chicago or San Francisco or Los Angeles
$110k-$135k/yrHybridFull Time
Stable Rock Solutions: Private professional-services platform providing outsourced finance, accounting, compliance, and operations support to investment managers and 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.
ReplimuneNasdaq: REPL: Public biotechnology developing oncolytic immunotherapies for patients with difficult-to-treat cancers.
8+ YOEBachelor's degree required; 8+ years of regulatory operations and publishing experience in biotechnology, pharmaceuticals, or related industries; expert Veeva Vault RIM expertise and global submission leadership required.
Veeva Vault RIM Submissions, Veeva Vault RIM Publishing, SEND, Veeva PromoMats, DXC, eCTD Xpress, ISI Toolbox, Lorenz, StartingPoint, eCTD, CTIS
MilliporeSigma: Merck KGaA's U.S./Canada life science business supplies research tools, bioprocessing products, and services to scientists and drugmakers.
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. Bank Global Fund Services: U.S. Bank Global Fund Services is a private fund administrator serving investment managers with administration, accounting, transfer-agent, and investor 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 PharmaNasdaq Global Select Market: AVLN: Public clinical-stage biopharmaceutical developing inhaled medicines for patients with pulmonary fibrosis and other rare lung 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.
Parabilis MedicinesNasdaq: PBLS: Clinical-stage biopharmaceutical developing Helicon peptide medicines for patients with serious diseases, especially cancer.
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.
CSL Behring: Global biotherapeutics leader driven by our promise to save lives.
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.
Durham or Cambridge or Waltham or Rockville or San Francisco
$139k-$231k/yrHybridFull Time
GSKLondon Stock Exchange (LSE): GSK: Global biopharmaceutical focused on medicines and vaccines.
1+ YOEBachelor’s degree in life sciences, pharmacy, medicine, or related field; 1+ year in regulatory affairs and drug development; oncology submissions and matrix-team experience required.
Bachelor's degree, 6+ years in Regulatory Affairs and 8+ years in biotech or pharmaceutical industry; regulatory filings, strategy, project management, communication, and regulatory interpretation experience required.
Investigational New Drug (IND), Clinical Trial Applications (CTAs), New Drug Applications (NDAs), spreadsheets, databases
Director, Regulatory Strategy – Global Regulatory Lead
Boston, Massachusetts, United States
$212k-$259k/yrHybridFull Time
Beeline Medicines: Clinical-stage biotechnology developing precision medicines for people with autoimmune and inflammatory diseases.
10+ YOE5+ MgmtAdvanced life sciences degree; 10+ years regulatory affairs; global regulatory leadership; experience with FDA/EMA; immunology/autoimmune knowledge.