Regulatory Submission Delivery Manager

IRI believes in commitment, integrity and strategic workforce solutions.

Integrated Resources, Inc., is led by a seasoned team with combined decades in the industry. We deliver strategic workforce solutions that help you manage your talent and business more efficiently and effectively. Since launching in 1996, IRI has attracted, assembled and retained key employees who are experts in their fields. This has helped us expand into new sectors and steadily grow.

We’ve stayed true to our focus of finding qualified and experienced professionals in our specialty areas. Our partner-employers know that they can rely on us to find the right match between their needs and the abilities of our top-tier candidates. By continually exceeding their expectations, we have built successful ongoing partnerships that help us stay true to our commitments of performance and integrity.

Our team works hard to deliver a tailored approach for each and every client, critical in matching the right employers with the right candidates. We forge partnerships that are meant for the long term and align skills and cultures. At IRI, we know that our success is directly tied to our clients’ success.

• 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