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Publisher
3 weeks ago
We are looking for an Regulatory Publisher to develop new challenging projects which would include the following responsibilities:
- 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.
**Education**
- Bachelor's degree in Life Sciences or related field, certificate in Regulatory Affairs is an asset
**Experience**
- 3 to 5 years' experience in Regulatory Operations with experience with electronic submissions, document formatting and eCTD publishing standards
**Skills**
- 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
**Job Types**: Full-time, Permanent
**Salary**: From $40,000.00 per year
Schedule:
- Day shift
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Publisher
4 weeks ago
Montréal, Canada ProductLife Group Full timeWe are looking for an Regulatory Publisher to develop new challenging projects which would include the following responsibilities: - 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,...
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