Senior Regulatory Publisher

Responsibilities:

• 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
• Excellent communication and interpersonal skills