Publisher

4 weeks ago

Montréal, Canada ProductLife Group Full time

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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