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Regulatory Affairs Associate
Long Beach, California, United States
$35-$40/hr OnsiteContract
3+ YOEBachelor's degree required (life sciences or chemistry preferred),3+ years regulatory affairs experience,proficiency with Microsoft Office,strong organizational and time-management skills.
Microsoft Office
2mo
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Senior Associate, Regulatory Affairs
Philadelphia or San Francisco
OnsiteFull Time
2+ YOEBachelor’s in life sciences; 2+ years Regulatory Affairs in biotech/pharma; oncology/IND experience; strong communication; regulatory submissions; FDA/ICH knowledge.
1w
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Senior Associate, Regulatory Affairs
Lake Forest, Illinois, United States
$98k-$140k/yr HybridFull Time
7+ YOEBachelor's degree in pharmacy/biology/chemistry/pharmacology/engineering required, 7+ years regulatory affairs experience in medical products, RAC preferred, strong communication, project management, and scientific reasoning.
EHR
2mo
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Sr Associate Regulatory Affairs
Berkeley Heights, New Jersey, United States
$90k-$125k/yr OnsiteFull Time
5+ YOEManage ANDA and post-approval submissions (eCTD), support lifecycle and combination-product regulatory strategy; 5+ years pharmaceutical regulatory affairs experience; bachelor\u0002s in pharmacy/chemistry/biology required; eCTD, MS Word, Excel, Adobe Acrobat experience; cGMP knowledge.
eCTD, Microsoft Word, Microsoft Excel, Adobe Acrobat
2mo
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Associate Director Regulatory Affairs
Waltham, Massachusetts, United States
$163k-$200k/yr OnsiteFull Time
10+ YOE10+ years Regulatory Affairs in biopharma; BS in science; experience with INDs/CTAs/NDAs/MAAs; strong regulatory strategy and communication.
Microsoft Office, SharePoint
1mo
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Associate Director, Regulatory Affairs
United States
$171k-$231k/yr HybridFull Time
6+ YOEBachelor's degree with 6+ years in regulatory affairs (8+ years in biotech/pharma), US regulatory filing experience, FDA interactions, strong communication, project management, and regulatory interpretation skills.
1w
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Senior Regulatory Affairs Associate
Elgin, Illinois, United States
OnsiteFull Time
5+ YOEBachelor's degree, 5+ years regulatory affairs experience in medical device/pharma, strong knowledge of FDA/Health Canada/EU regulations, ISO 13485:2016, sterilization processes, audit and CAPA management, Microsoft Office and Dynamics GP.
Microsoft Office, Microsoft Dynamics GP
2mo
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Associate Director, Regulatory Affairs
Bothell, Washington, United States
$178k-$213k/yr OnsiteFull Time
7+ YOE7+ years regulatory affairs experience, oncology/rare disease focus; strong project management and cross-functional collaboration.
Veeva Vault
5d
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Regulatory Affairs Associate II
Seattle, Washington, United States
$92k-$125k/yr OnsiteFull Time
5+ YOEBachelor's degree in life sciences or related field,5+ years regulatory affairs experience in FDA-regulated IVD environment (or PhD with 2+ years),experience with EUA/510(k)/De Novo/PMA submissions,knowledge of US and international IVD regs,certification preferred.
Microsoft Office, Microsoft SharePoint, statistical packages
3w
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Associate Director, Regulatory Affairs
South San Francisco, California, United States
$201k-$234k/yr HybridFull Time
8+ YOEBachelor's degree required; 8+ years drug development including 5+ years regulatory affairs in biotech/pharma; knowledge of FDA/EMA/ICH and GxP; experience with IND/CTA/eCTD submissions and health authority interactions; strong communication and organizational skills.
eCTD
2w
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Regulatory Affairs Associate
San Francisco, California, United States
$38/hr OnsiteFull Time
Coordinate and manage IRB submissions, maintain study documentation, draft SOPs, implement quality management, and provide regulatory guidance for biomedical intervention studies.
Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Microsoft Access, Trello
2mo
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Senior Associate, Regulatory Affairs (US)
United States
$41-$53/hr RemoteFull Time
3+ YOERegulatory affairs experience with US IND/NDA/BLA submissions; end-to-end submission management; strong cross-functional collaboration.
Veeva Vault BRIM, eCTD, Adobe Acrobat, Microsoft Office
2mo
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Regulatory Affairs Associate
Doral, Florida, United States
OnsiteFull Time
3+ YOEBachelor's in life science, 3+ years lab/medical device experience with urinalysis or microscopy, clinical study experience preferred, ability to travel domestically/internationally, proficiency in Microsoft Office and Adobe, familiarity with quality/regulatory standards.
Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Adobe
1mo
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Regulatory Affairs Associate
Boerne, Texas, United States
$25-$30/hr OnsiteFull Time
2+ YOEHigh school diploma or equivalent; legally authorized to work in the US; 2+ years quality/regulatory experience in medical device/IVD/biotech/pharma; knowledge of ISO 9001, ISO 13485, and 21 CFR Part 820; ERP and submission experience preferred.
ProAlpha, Oracle, SAP, AS400, Microsoft Word, Microsoft Excel, Microsoft Outlook
1mo
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Associate Director, Regulatory Affairs
United States
$170k-$200k/yr RemoteFull Time
5+ YOE10+ years regulatory affairs experience (Bachelor\u0002s) or 8 years (Master\u0002s) or 5+ years (PhD); BS in life sciences required; late-stage oncology and global regulatory experience; strong writing, negotiation, and project management skills.
3w
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Regulatory Affairs Associate
New York City, New York, United States
$60k-$70k/yr RemoteFull Time
2+ YOECoordinate policy development and maintenance, maintain documentation and review cycles, support compliance initiatives, audits, training, and policy implementation; associate degree required, 2–4 years preferred.
Microsoft Office Suite
3mo
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Associate Director, Regulatory Affairs
Boston, Massachusetts, United States
$171k-$204k/yr RemoteFull Time
6+ YOE6+ years in Regulatory Affairs; US/global strategy; IND/CTA/NDA/BLA/MAA experience; knowledge of GxP, ICH, FDA guidance; strong communication; US-based remote with quarterly travel to Boston.
1w
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Quality - Regulatory Affairs Associate
Totowa, New Jersey, United States
$58k-$70k/yr OnsiteFull Time
2+ YOEBachelor's degree in life sciences/engineering, 2+ years cosmetics or regulatory experience, familiarity with drug and cosmetic regulatory processes and 21 CFR Parts 210/211, audit and documentation experience, computer literacy.
1mo
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Sr. Manager/Associate Director, Regulatory Affairs
Menlo Park or Waltham or United States
$161k-$208k/yr HybridFull Time
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.
2d
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Plasma Regulatory Affairs Associate
Research Triangle Park, North Carolina, United States
OnsiteFull Time
Bachelor's in a scientific discipline; experience preparing and submitting regulatory/licensing applications; familiarity with FDA/CLIA/PPTA/COLA requirements; Microsoft Office and Adobe PDF experience; regulated industry experience preferred.
Microsoft Office, Adobe PDF
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