Regulatory Affairs associate I – RA publishing will participate in the publishing of different regulatory activities. The focus will be to ensure 100% quality and timeline of the submission. This role will be the primary interface with the Regulatory Affairs Associate. The Associate should have experience to perform US, EU and Canada submissions.
How you’ll spend your day
- Publish and dispatch major and complex routine/lifecycle management eCTD submission projects for EU, US and Canada
- Exposure in handling post approval submissions publishing and transmitting quality submissions to agency.
- Perform document level publishing activities, troubleshoot document issues and perform quality control checks for submission ready documents as per the agency guidance.
- Collaborate with scientific personnel for planning, preparation, publishing and quality control checks of submissions.
- Maintain working knowledge of internal and external publishing standards.
- Basic knowledge of ICH and eCTD related specification/guidelines governing regulatory submissions (eCTD, NeeS, paper)
- Must be aware of technical systems like Global Insight, ISI Toolbox, Adobe Acrobat, Lorenz Validator