Description
We are looking for a
eCTD Regulatory Submission Specialist (m/f)
Reference: -en
Start: ASAP
Duration: 12 MM++
Place: in Basel-City
Branch: Herstellung von pharmazeutischen Erzeugnissen
Your tasks:
- Planning, compiling, coordinating and tracking eCTD submissions of EU procedures, providing eCTD expertise where required to ensure all submissions are effectively executed
- Check electronic documents and reformat to standards as required, to ensure eCTD compliance
- Be responsible for submission compilation: assigning metadata, locations within the eCTD modular structure building XML backbone, eCTD leaf titles, lifecycle operators in accordance with company procedures and standards
- Liaise with a submissions outsourcing partner on these activities when required by DRA management
Your qualifications
- Experience in making electronic submissions in eCTD format
- Fundamental understanding of eCTD regulatory guidance in the EU
- Understanding of eCTD regulatory guidance in countries outside of EU & US (e.g. Saudi Arabia, Thailand, etc.) would be an advantage
- Fluency in English
Skills:
- Regulatory affairs manager