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 Consultantwhere 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

Requirements

Life Science Graduate + solid academic background in Life Sciences;

5+ years proven professional experience in associated fields;

Experience in analyzing, writing and summarizing;

Able to train/coach less experienced consultants.

Direct interactions with regulatory agencies is a plus;

Experience in a consulting environment is a plus;

Good command of MS Office (Word, Excel, PowerPoint);

Experience in Project Management.

Strong problem solving skills;

Demonstrated ability to manage and build relationships with colleagues and regulatory authorities;

Qualification

Associate Degree