Project Title (Mandatory): Regulatory Submissions Management and Operations for Janssen R&D
Project Goal (Mandatory): The management and delivery of regulatory submissions to global health
authorities required to support the maintenance, development, and registration of products
Project Timing (Mandatory): January 01, 2022 – December 31, 2022
Services Location (Mandatory): Services will be performed at Buyer’s facility at the following location:
1125 Trenton-Harbourton Rd, Titusville, NJ 08560
920 Route 202 South, Raritan, NJ 08869
Deliverables to be performed:
· Establish Dossier Plans for the assigned global submission types as needed to support the lifecycle of one or more products.
· Generate dossier plans that will reflect inputs from functional area representatives and key stakeholders, meeting regularly with submission stakeholders and cross-functional representatives to identify and resolve issues and to assess quality and delivery of Dossier Plans, quality of deliverables and timelines against established KPIs.
· Ensure relevant submission process(es) are applied to all assigned submissions, including coordinating the electronic component and dossier level publishing and production of regulatory submissions that conform to regional and country specific regulatory requirements as appropriate.
· Ensure dispatch/distribution in compliance with due dates to Health Authorities and/or Local Operating Companies, as applicable, tracking submission events/activities in appropriate systems/tools.
· Support development of departmental work practices, process enhancements, and associated training materials.
· Develop/maintain associated process tools and relevant training documentation.
· Support compliance needs as appropriate. Apply appropriate regulatory submission standards, requirements, processes and policies to comply with applicable health agency requirements; Maintain open, timely and effective communications with all publishing contributors and responsible RA professional, to ensure timely delivery of dossier components and/or complete dossier for submission; Participate on special projects and process improvement initiatives, as needed.