eCTD Specialist

As consultant - to author and deliver in a timely manner high quality scientific documents to align with product development and registration strategy addressing multiple client projects.

As Lead Consultant - where applicable: ensure smooth and close communication with the client. Monitor, prioritize and supervise project activities. Communicate as appropriate to project team members and to the Account Manager.

Manage and mentor less experienced colleagues, depending on organizational needs.

- Management of Publishing projects, maintaining submission trackers, ensuring quality and timeliness of Client deliverables and submissions

- Prepare, assemble, and submit applications (IND/CTA/NDA/MAA/NDA), etc

- Creating eCTD compliant PDFs, publishing sequences in docuBridge, creating internal and external document hyperlinks

- Work in close collaboration with Global Regulatory teams when Publishing is included in a larger project

- Perform technical QC of submissions before dispatch to Regulatory Authorities, ensure submissions are published in accordance with the relevant ICH and local guidelines and internal procedures

- Dispatch submissions to Regulatory Authorities via agency portals

- Communicate with regulatory agencies with respect to electronic regulatory submissions, answering technical queries, resolving technical issues (with relevant ITsupport)

- Stay abreast of ICH and regional requirements and ensure publishing software is in line with regional eCTD validation criteria

- Create tools for easier management of submissions/tasks

- Participate in the update of internal eCTD Distinct Technical Procedures (DTPs)

- Provide training and mentoring to eCTD Specialists (when applicable)

- Other duties as assigned

Life Science Graduate + solid academic background in Life Sciences;

5+ years proven professional experience in associated fields;

Experience in analyzing, writing and summarizing;

Abl