Location:
Remote (EST time zone)
Schedule:
Standard Office Hours
Duration:
12-Month Contract
Pay range:$55.00 - $65.00/hr
Responsibilities
- Manage eCTD submissions across a broad product portfolio to global Health Authorities, supporting both development and lifecycle management activities.
- Coordinate all publishing deliverables in alignment with the strategic direction of assigned programs and products.
- Oversee outsourced publishing deliverables on a day-to-day basis to ensure successful execution of operational activities.
- Serve as the primary point of contact for regulatory functions throughout the product lifecycle.
- Ensure submission deliverables are incorporated and visible to all relevant stakeholders.
- Monitor handoffs and deliverables from the authoring community, ensuring timeliness, adherence to submission standards, and high-quality outputs.
- Drive deliverable timelines in partnership with Regulatory Submission Managers and authoring teams, while setting appropriate standards and expectations for quality.
- Ensure electronic submissions and documents meet regulatory agency standards and technical requirements.
- Perform quality control checks on eCTD components, final submissions, hyperlinks, and bookmarks, ensuring compliance with local Health Authority guidelines.
- Demonstrate expert knowledge of submission-related or technology-related Health Authority guidelines and regulations.
Requirements
- 3–5 years of experience in regulatory operations supporting submission delivery for the US and Europe.
- Strong knowledge of eCTD structure and global submission standards.
- Proficiency with electronic document management systems and publishing tools.
- Demonstrated ability to manage timelines, deliverables, and cross-functional handoffs.
- Strong attention to detail and commitment to high-quality outputs.
- Experience managing or overseeing publishing vendors preferred.
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