193 regulatory associate jobs at 107 companies in Bristol, RI

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Regulatory Reporting Associate
Stamford or Orlando or Providence or Toronto or United States or Canada or North America
$90k/yr HybridFull Time
Moneycorp
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
3d
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Associate Director, Regulatory Affairs
United States or Cambridge or Philadelphia
$171k-$231k/yr HybridFull Time
Alnylam Pharmaceuticals
Alnylam PharmaceuticalsNasdaq: ALNY: Biopharmaceutical developing RNAi medicines.
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
4d
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Associate Director, Regulatory Affairs
Cambridge or Philadelphia or Cambridge or Philadelphia or Boston
$171k-$231k/yr HybridFull Time
Alnylam Pharmaceuticals
Alnylam PharmaceuticalsNasdaq: ALNY: Biopharmaceutical developing RNAi medicines.
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
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Regulatory Strategy Associate Director
Boston, Massachusetts, United States
$168k-$252k/yr HybridFull Time
Vertex Pharmaceuticals
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.
3mo
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Associate Director Regulatory Affairs
Waltham, Massachusetts, United States
$163k-$200k/yr OnsiteFull Time
Viridian Therapeutics
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.
Microsoft Office, SharePoint
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Associate Director, Regulatory Science
Boston, Massachusetts, United States
$190k-$240k/yr HybridFull Time
Orchard Therapeutics plc
Orchard Therapeutics plc: Private biotechnology developing ex vivo HSC gene therapies for patients with rare genetic diseases.
US regulatory strategy and execution experience for biologics/ATMPs; strong knowledge of US CFR/FDA; IND/BLA submission experience; team leadership and regulatory submission project management; PharmD or PhD required.
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Associate Director, Regulatory Affairs
United States or New York or Boston
$190k-$200k/yr HybridFull Time
Nuvation Bio
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%.
eCTD, e-publishing systems
2w
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Associate Director, Regulatory Affairs
Boston, Massachusetts, United States
$175k-$219k/yr HybridFull Time
Foundation Medicine
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.
FDA, HIPAA, Next Generation Sequencing (NGS)
1w
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Associate Director, Regulatory Affairs
Cambridge, Massachusetts, United States
$170k-$195k/yr RemoteFull Time
Parabilis Medicines
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.
FDA, AI
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Associate Director Regulatory Affairs, Oncology
Upper Providence or Waltham or Rockville or Durham or Cambridge or San Francisco
$139k-$231k/yr HybridFull Time
GSK
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.
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Associate Director Global Regulatory Sciences - Oncology
Princeton or Cambridge
$173k-$210k/yr OnsiteFull Time
Bristol Myers Squibb
Bristol Myers SquibbNYSE: BMY: Transforming patients' lives through science.
4+ YOEPharmaceutical regulatory experience; advanced scientific degree preferred; 4+ years pharma experience with 3+ years in regulatory affairs; experience preparing IND/NDA/BLA submissions and leading regulatory interactions with health authorities.
2mo
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Associate Director, Global Regulatory Lead, Oncology
Boston or Cambridge
$154k-$243k/yr HybridFull Time
Takeda
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.
1mo
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Associate Director, Global Regulatory Affairs
Waltham, Massachusetts, United States
$155k-$190k/yr HybridFull Time
Kailera Therapeutics
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%.
3w
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Associate Director / Director, Regulatory Affairs
Watertown, Massachusetts, United States
OnsiteFull Time
Treeline Biosciences
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.
2mo
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Associate Director, Regulatory Affairs Operations
Cambridge, Massachusetts, United States
$200k-$240k/yr OnsiteFull Time
Merida Biosciences
Merida Biosciences: Private biotechnology developing precision Fc biotherapeutics that selectively eliminate pathogenic antibodies for autoimmune and allergic disease patients.
7+ YOEBachelors in life sciences required; 7+ years regulatory affairs/operations experience in pharma/biotech; experience with RIMS/EDMS/Veeva Vault, eCTD, project planning tools and Microsoft Office; knowledge of FDA/EMA/ICH standards.
RIMS, EDMS, Veeva Vault Regulatory, eCTD, Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Microsoft Teams, Smartsheet, Microsoft Project
1mo
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Associate Director, Regulatory CMC (Biologics)
Waltham, Massachusetts, United States
$182k-$208k/yr HybridFull Time
Oruka Therapeutics
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.
5d
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Associate Director, Regulatory Affairs - Advertising/Promotion (REMOTE)
Boston, Massachusetts, United States
RemoteFull Time
MannKind Corporation
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
1w
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Associate Director, Regulatory Starting Material
Boston, Massachusetts, United States
$140k-$210k/yr OnsiteFull Time
Centessa Pharmaceuticals
Centessa PharmaceuticalsNASDAQ: CNTA: Lilly-owned clinical-stage biopharmaceutical developing orexin receptor 2 agonists for patients with sleep-wake disorders.
8+ YOEAdvanced degree in chemistry, chemical engineering, or related field; 8–10 years of CMC, process chemistry, or drug substance/API experience; expertise in ICH Q11, cGMP, regulatory submissions, and health authority interactions.
ICH Q11, Module 3, INDs, NDAs, MAAs, cGMP
3mo
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Associate Director, Global Regulatory, CMC
Norwood, Massachusetts, United States
$143k-$257k/yr OnsiteFull Time
Moderna
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.
2w
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Associate Director/Director, Regulatory Strategy
Boston, Massachusetts, United States
$200k-$225k/yr HybridFull Time
Rapport Therapeutics
Rapport TherapeuticsNasdaq Global Market: RAPP: Public clinical-stage biopharmaceutical developing precision small-molecule medicines for neurological and psychiatric disorders.
8+ YOEBachelor’s degree in life science or related discipline and 8–10 years in pharmaceutical or biotech industry with significant Regulatory Affairs experience; leadership, communication, and global development expertise required.
FDA, EMA, INDs, CTAs, NDAs

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