Principal responsibilities focus on the coordination and/or publishing of product lifespan submissions.
Associate (Specialist 2) Generally coordinates and compiles, dossier plans and possibly publishes
Senior Associate (Specialist 3): Ensures compliance with regulatory agency regulations and
interpretations. Coordinates and compiles, dossier plans and possibly publishes submission
Lead Associate (Specialist 4) – Gathers and assembles and/or publishes information necessary for
submissions in accordance with regulations and relevant guidelines.
Manager (Manager 1): - Coordinates the preparation and maintenance of regulatory submissions and
Associate Director (Manager 2) –. Directs and coordinates activities concerned with the submission and
approval products to government regulatory agencies. Provides guidance to project team members.
These responsibilities, including complexity and scope of submissions, may vary depending on role of employee
and may include but are not limited to the following:
Manage preparation and/or publishing of submissions across the product lifespan in line with Regulatory
Partner across GRA and functional area contributing groups as needed for assigned projects.
Establish the Dossier Plan(s) for the lifecycle submissions considering inputs from functional area
representatives and key stakeholders.
Establish and maintain effective interactions with key partners as appropriate to ensure priority conflicts,
resource issues and deviations from the plan are identified and resolved.
Ensure that all required documents are included in the dossier.
Track submission events/activities in appropriate systems/tools.
Liaise with RSMO staff as required.
Support development of departmental work practices, process enhancements / improvements, and associated training materials.
Monitor the effectiveness of the submission process and initiate changes within the scope of decisionmaking
authority to minimize inefficiencies and ensure / improve quality.
Represent RSMO function on Janssen initiatives where appropriate.
Develop/maintain associated process tools and relevant training documentation.
Support compliance needs as appropriate.
May have following publishing activities as defined by the particular role or job function.
Determine the scope of the electronic publishing requirements for the dossier
Utilize current electronic document management and publishing technologies to assemble and publish dossiers according to regulatory requirements for paper and electronic submissions with a high degree of independence
Provide component-level publishing support for Regulatory-owned deliverables in PDF format to ensure dossier components conform to submission standards (e.g., bookmarking, linking, PDF version, etc.)
Apply appropriate regulatory submission standards, requirements, processes and policies to comply with applicable health agency requirements
QC electronic and paper submissions to ensure compliance with company and applicable health agencyrequirements
Maintain openly, 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
Cultivate ongoing effective relationships with publishing contributors across LSM and RA Therapeutic Areas