Regulatory Submission Delivery Manager

• The Regulatory Submission Delivery Manager is responsible for the coordination of publishing deliverables, in line with the strategic direction of the programs/products

• Act as the primary point of contact for publishing staff, managing day to day workload and responsibilities

• Act as point of contact for various regulatory functions (i.e. CMC, Development, and Labelling) as appropriate in the products lifecycle

• Partner with planning and tracking to ensure submission deliverables are incorporated and visible to all stakeholders

• Ensure hand offs and deliverables from authoring community are on time in line with the submission standards and expectations of quality

• Primary point of contact for all operational activities (e.g., allocate and track publishing, formats, templates,, technical requirements)

• Oversee publishing deliverables on a day to day basis to ensure successful execution of operational activities for assigned products

• Coordinates and tracks delivery of required content with content owners for routine / maintenance submissions in all markets

• 8 years Regulatory submissions experience with expertise in eCTD submissions

• Experience with Liquent tools is preferable

• Ability to manage competing priorities and fast-moving requirements

Thanks

Warm Regards

Ricky

732-429-1925