94 regulatory compliance associate jobs at 70 companies in Mendon, MA
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Associate Manager CMC Regulatory Compliance
Billerica, Massachusetts, United States
$78k-$117k/yrHybridFull Time
MilliporeSigma: Merck KGaA's U.S./Canada life science business supplies research tools, bioprocessing products, and services to scientists and drugmakers.
1+ YOEBachelor's degree in life science and 1+ year of pharmaceutical or academic experience with regulatory or CMC knowledge. Strong communication and regulatory documentation skills required.
MilliporeSigma: Merck KGaA's U.S./Canada life science business supplies research tools, bioprocessing products, and services to scientists and drugmakers.
1+ YOEBachelor's degree in life science, 1+ year pharmaceutical or academic experience, and regulatory or CMC knowledge. Requires CMC strategy, dossier, documentation, and strong written and verbal communication skills.
American TowerNYSE: AMT: Public U.S. REIT that owns, operates, and leases wireless towers, communications sites, and data centers to connectivity providers.
Associate or bachelor's degree in environmental science or similar preferred; project, database, and file management experience preferred; regulatory knowledge, communication, organization, and cross-functional collaboration skills required.
Associate Director, Global Regulatory Affairs Compliance
Cambridge or San Francisco or Boston
$190k-$210k/yrHybridFull Time
Olema OncologyNasdaq: OLMA: Clinical-stage biopharmaceutical developing targeted therapies for patients with metastatic breast cancer and other solid tumors.
8+ YOEBachelor’s degree in a scientific or related discipline, 8+ years of pharmaceutical or biotechnology regulatory affairs experience, regulatory writing expertise, and strong organizational, communication, judgment, and collaboration skills.
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.
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
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
6+ YOEBachelor's degree and 6+ years in Regulatory Affairs, including 8+ years in biotech or pharmaceutical industry; regulatory filings, strategy, project management, communication, and regulatory guidance experience required.
word processing, spreadsheets, databases, online research
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.
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
Vertex PharmaceuticalsNASDAQ: VRTX: Global biotechnology investing in scientific innovation.
8+ YOEBachelor's in biology/chemistry or related; typically 8 years regulatory experience in pharma/biotech; expertise with global/regional regulatory frameworks, health authority submissions, and ability to lead regulatory strategy and mentor teams.
Nuvation BioNYSE: NUVB: Public oncology biopharmaceutical developing and commercializing cancer medicines for patients with difficult-to-treat cancers.
10+ YOEBachelor's or Master's required, 10+ years regulatory drug development experience, eCTD and submission authoring experience, deep FDA knowledge, ability to travel up to 10%.
Foundation Medicine: Foundation Medicine is a precision-medicine developing genomic diagnostic tests for cancer patients, clinicians, researchers, and biopharma companies.
8+ YOE4+ MgmtRequires a bachelor's degree with 8+ years, master's with 6+ years, or doctorate with 3+ years in a relevant life sciences field, plus 4+ years of management and regulatory affairs experience.
Parabilis MedicinesNasdaq: PBLS: Clinical-stage biopharmaceutical developing Helicon peptide medicines for patients with serious diseases, especially cancer.
7+ YOEBachelor’s degree in a scientific discipline required; 7+ years in pharmaceutical or biotech industry, including 4+ years in Regulatory Affairs. Oncology, global submissions, FDA NDA/BLA, leadership, and AI tool experience required or preferred.
Associate Director, Global Regulatory Lead, Oncology
Boston or Cambridge
$154k-$243k/yrHybridFull Time
TakedaTokyo Stock Exchange: 4502: Global research-driven biopharmaceutical.
6+ YOELead global regulatory strategies for oncology programs, oversee major submissions, manage FDA interactions, collaborate cross-functionally, and mentor regulatory 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%.
Treeline Biosciences: Clinical-stage biopharmaceutical developing inhibitors, protein degraders, and antibody-drug conjugates 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.
MannKind CorporationThe Nasdaq Stock Market LLC: MNKD: Biopharmaceutical developing and commercializing treatments for cardiometabolic and orphan lung diseases.
7+ YOEBachelor's degree and 7+ years of pharmaceutical Regulatory Affairs experience, including labeling and advertising/promotional materials; requires regulatory interpretation, risk assessment, communication, and cross-functional leadership skills.
Veeva Vault, Veeva Vault PromoMats, electronic document management system
AmerescoNew York Stock Exchange: AMRC: Publicly traded energy infrastructure and cleantech firm serving governments, utilities, institutions, and commercial and industrial customers.
2+ YOEBachelor's or master's in business/economics/energy/engineering, minimum 2 years regulatory/compliance experience (NERC preferred), strong MS Word/Excel skills, ability to manage priorities and work with stakeholders.
Microsoft Word, Microsoft Excel, VBA, Python, SQL, EIA-860, EIA-923, FERC EQR
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.