“eCTD document management system” jobs in Canada

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• 12d

  Senior Regulatory Associate New Product Development and Medical Devices

  Toronto, ON

  

  Fresenius Kabi Canada: Fresenius Kabi Canada is a diverse pharmaceutical company committed to supplying high quality, cost-effective pharmaceutical products and services…

  4+ YOECandidates need a Bachelor of Science in a life science and at least four years of regulatory affairs experience in pharmaceuticals or medical devices. Strong knowledge of Health Canada medical device rules, pharmaceutical manufacturing requirements, eCTD systems and Microsoft Office is required.

  Microsoft Office 365, Adobe Acrobat, eCTD document management system

• 25d

  Senior Specialist, Regulatory CMC

  Remote in Canada

  RemoteFull Time

  MP

  Medexus Pharma

  3+ YOECandidates need a life science degree, 3+ years of pharmaceutical or biologics regulatory affairs experience with post-approval CMC work, and experience preparing or coordinating Health Canada or FDA submissions. Working knowledge of Module 3 quality documentation and pharmaceutical quality systems is required.

  eCTD

• 27d

  Senior CMC Regulatory Affairs Manager

  Vancouver, BC

  $150k–$180k/yrFull Time

  

  AbCellera: AbCellera is a clinical-stage biotechnology company focused on discovering and developing antibody-based medicines in the areas of endocrinology,…

  8+ YOECandidates need deep knowledge of CMC regulatory requirements, eCTD structure and Module 3 authoring for biologics and combination products. They also need a thorough understanding of Health Canada, FDA and EMA rules, a bachelor's or advanced degree in a science or engineering field, and about 8 years of relevant experience.

  Regulatory affairs, Documentation, CTAS, Regulatory compliance

• 27d

  Manager, Regulatory Affairs (CMC)

  Canada

  

  Telix Pharmaceuticals (AMER): Telix is a biopharmaceutical company focused on the development and commercialisation of therapeutic and diagnostic ('theranostic')…

  7+ YOETelix Pharmaceuticals needs 7+ years of CMC experience in radiopharmaceutical or biopharmaceutical industries, strong technical writing and knowledge of ICH, FDA and EMA requirements. An undergraduate degree is required and an advanced degree is preferred.

  Veeva

• 28d

  Senior Regulatory Operations Specialist

  Toronto, ON +10

  Full Time

  

  Cencora: Cencora, a company building on the legacy of AmerisourceBergen, is a leading global pharmaceutical solutions organization centered on improving the…

  5+ YOECandidates need at least 5 years of daily regulatory operations experience, a life sciences degree or equivalent, and strong knowledge of Canadian and U.S. submission types. Advanced Microsoft Office, Adobe Acrobat, IT and project management skills are expected.

  eCTD builder, eCTD validation software, eCTD viewer, ESG NextGen Portal, Microsoft Word, Adobe Acrobat

• 29d

  Senior Nonclinical Writer (Remote - Canada)

  Toronto, ON

  Full Time

  

  MMS

  5+ YOECandidates need 5+ years of pharmaceutical regulatory nonclinical writing experience and a bachelor's degree in pharmacology, toxicology, biology, chemistry or a related field. They need strong writing and analytical skills, knowledge of GLP and ICH guidelines, and the ability to lead complex projects and client meetings.

  Veeva RIM, SharePoint, PleaseReview, EndNote, MS Office

• 29d

  Senior Regulatory Operations Specialist

  Ontario

  RemoteFull Time

  IS

  Innomar Strategies

  5+ YOECandidates need at least 5 years of hands-on Regulatory Operations experience and a life sciences background. They must know Canadian and U.S. submission types, eCTD and NeeS, and advanced Microsoft Office and Adobe Acrobat, and handle tight deadlines with strong attention to detail.

  Microsoft Word, Adobe Acrobat, Microsoft Excel, eCTD submission builder, eCTD validation software, electronic submissions viewer

7 companies