Regulatory Submission Specialist
Collaborate with collleagues coordinating and tracking eCTD submissions for EU procedures, providing eCTD expertise where required to ensure all submissions are effectively executed.
- Collaborate with collleagues coordinating and tracking eCTD submissions for EU procedures, providing eCTD expertise where required to ensure all submissions are effectively executed.
- As required, provide support to the Regional Management Group for national submissions according to regional guidances.
- Publish documents for electronic submissions in eCTD format using appropriate tools.
- 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 (with guidance from document authors where necessary), building XML backbone, eCTD leaf titles, lifecycle operators in accordance with company procedures and standards. Where required by DRA management, liaise with a submissions outsourcing partner on these activities.
- Be responsible for quality control of the submission, its contents and backbone, both manually and through appropriate validation software applications.
Qualifications and Experience:
- A minimum of two years of experience in making electronic submissions in eCTD format
- Fundamental understanding of eCTD regulatory guidance in the EU
- Excellent Acrobat skills and experience in electronic publishing of documents
- Committed attention to detail: accurate and meticulous
- Proven ability to work independently and under pressure (able to prioritize tasks, deadline-oriented, good organizational skills) and as a team member
- Ability to problem solve complex problems (strong analytical skills)
- Self-motivated, with initiative and ability to work in a fast-paced, high-volume environment
- Ability to communicate effectively in English (spoken and written)
- Experience of working effectively in a cross-cultural environment preferred
- Experience of working effectively in a matrix environment preferred
- Customer-oriented attitude