Regulatory Publishing AssociateBookmark This
Green Key Resources
- Electronic Publishing and quality-control checking of assigned regulatory submissions.
- Preparation and dispatch of paper-based submissions.
- Ensure compliance of submissions with all applicable regulations, guidances, and Regulatory Operations procedures and document specifications.
- Maintains the Regulatory Archives, electronic files, and communications databases.
- Bachelor's degree in a relevant discipline plus 5 to 7 years of experience or Associate's degree in a relevant discipline plus 7 to 10 years of experience.
- 3 to 5 years' of overall experience in a lead publishing role in the pharmaceutical/biotechnology industry.
- Expertise in Microsoft Office and Adobe Acrobat software.
- Thorough knowledge of CTD/eCTD format and FDA submission requirements.
- Extensive experience with eCTD publishing.
- Experience with databases and/or document management systems.
- Understanding of technologies to support electronic submissions and labeling.