Manage and prepare IND, NDA, BLA, and DMF regulatory applications in eCTD format for submission to the applicable regulatory authority (FDA/HC) in compliance with required timelines and specifications.
Perform quality control procedures to ensure completion, correctness, navigability, and adherence to regulatory eCTD guidelines.
Perform document management tasks and post-submission activities including file transfer, tracking, database updates and archival.
Maintain current knowledge of FDA, HC, and ICH requirements for regulatory submissions, and ensure compliance accordingly.
Collaborate with global functional areas to ensure submission-related deliverables are met to achieve strategic business goals.
Requirements:
Bachelor's degree in Life Sciences or related field, certificate in Regulatory Affairs is an asset
5 to 8 years' experience in Regulatory Operations with experience with electronic submissions, document formatting and eCTD publishing standards
In-depth knowledge of technologies utilized for creation and management of regulatory submissions and publishing softwares such as Insight Publisher, Lorenz Docubridge, eCTD Xpress...
Mastery of handling tools such as "ISI Toolbox", "Adobe Acrobat Pro", "Liquent Smart Desk", and other eCTD related softwares
Attention to detail and project management skills and ability to work independently
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