“eCTD” jobs in Canada

No matching filters. Try another name.

Results

• 4d

  Sponsor Dedicated Senior Medical Writer (Regulatory Submission Documents) - Canada Remote Based

  Remote in Canada

  RemoteFull Time

  SH

  Syneos Health Canada Inc.

  3+ YOECandidates need 3 to 5 years of medical writing experience with protocol writing, plus biopharmaceutical, device or CRO industry experience. Strong knowledge of FDA and ICH regulations, English grammar and the AMA Manual of Style is required, and experience with Veeva/CARA, oncology/hematology or cell therapy and late development is valued.

  Veeva, CARA

• 8d

  Sponsor Dedicated Protocol Medical Writer II - Remote based (Canada, US, UK, Serbia)

  Remote in Canada

  RemoteFull Time

  

  Syneos Health, LLC

  3+ YOESyneos Health needs candidates with 3 to 5 years of medical writing experience, including protocol writing, and experience in biopharmaceutical, device or CRO settings. Strong knowledge of FDA and ICH regulations, excellent English and AMA style, and experience with Veeva/CARA are needed.

  Veeva, CARA

  15d

  Sr. / Principal Medical Writer (Regulatory focus) - Sponsor-dedicated; NA/CAN/UK

  Remote in Canada

  RemoteFull Time

  

  Syneos Health, LLC

  5+ YOECandidates need at least 5 years of lead regulatory writing experience, including Phase 2 and 3 studies and documents such as CSRs, IBs, patient narratives and integrated summaries. Strong project management, client-facing and time management skills are required.

  eCTD

• 10d

  Regulatory and Clinical Research Coordinator

  Ontario

  $64k–$91k/yr

  WU

  Western University

  2+ YOECandidates need a BSc, RRT, RN/BScN or RPN, or equivalent, plus about 2 years of research support experience and regulatory experience, preferably with Health Canada and ethics submissions. They also need strong project management, database (REDCap), writing and communication skills.

  REDCap, eCTD, Relational databases

• 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

• 15d

  Gestionnaire principal(e), Affaires réglementaires CMC

  Montréal, QC

  Full Time

  

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

  8+ YOEConnaissance approfondie des exigences CMC et de la structure eCTD; Expérience de rédaction du module 3 pour produits biologiques et combinés; Maîtrise de la réglementation de Santé Canada, de la FDA et de l'EMA

  eCTD

  28d

  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

• 16d

  Senior Regulatory Affairs Associate

  London, ON

  Full Time

  BB

  BLES Biochemicals

  3+ YOECandidates need a university degree in a life science, a post-graduate certification in regulatory affairs and at least 3 to 5 years of hands-on regulatory affairs experience in pharmaceuticals, biologics or medical devices.

  eCTD

• 17d

  Publisher (Report Services)

  Quebec

  $23/hrRemote

  CR

  Charles River

  Candidates need a college diploma, prior experience in publishing or information technology, and strong written English, with French preferred. Proficiency with Microsoft Office is required; training is provided for the rest.

  Microsoft Word, Microsoft Office, Publishing software

• 26d

  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

• 28d

  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

• 1mo

  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

12 companies