Regulatory Affairs Manager II

Job Description

Duties and Responsibilities:

• Performs eCTD submission management across client’s product portfolio to Health Authorities for global development and lifecycle management submissions.
• The Regulatory Ops. 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.
• 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.

Requirements:

• 5 plus years in Regulatory Operations.
• They must know regulations and have insight on what to look for in the ECTD documents.
• Must be knowledgeable with US region regulations with regard to ECTD submission, Must be able to meet deadlines and oversee deliverables on document submissions.