Regulatory Affairs Consultant

Job Description

Job Summary:

• Performs eCTD submission management across client’s product portfolio to Health Authorities for global development and lifecycle management submissions.
• The Regulatory Operations Manager is responsible for the coordination of all publishing deliverables, in line with the strategic direction of their assigned programs/products. Oversee outsourced publishing deliverables on a day-to-day basis to ensure successful execution of operational activities for assigned products.
• Acts as the primary point of contact for regulatory functions as appropriate in the products lifecycle.
• The Regulatory Ops. Manager ensures submission deliverables are incorporated and visible to all stakeholders.
• Ensures hand offs and deliverables from authoring community are on time and in line with the submission standards and expectations of quality.
• Drives deliverable timelines with RSM (RA Regulatory Submission Manager) and authoring community and sets appropriate standards and expectations of quality.

Duties and Responsibilities:

• Responsible for electronic submissions and documents meeting regulatory agency and client submission standards and technical requirements.
  Quality control checks on electronic common technical (eCTD) components, final submissions, hyperlinks and bookmarks, and ensures submissions adhere to local health authority guidelines.
• Demonstrates expert knowledge of submission or technology-related Health authority guidelines/regulations. Competent in the use of electronic document management and submissions publishing tools.

Education and Experience:

• 3-5 years of experience in regulatory operations providing submission delivery support for the US and Europe.
• Experience overseeing publishing vendors preferred.
• Must have 3-5 years of Submission Delivery Support experience, must have US and European regulatory knowledge.
• Experience with managing publishing vendors is a plus.