About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https: //www.jnj.com/innovative-medicine

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):

US (Titusville, NJ; Raritan, NJ; Horsham, PA) - Requisition Number: 2506229584W

High Wycombe, UK - Requisition Number: R-009929

Allschwil, Switzerland - Requisition Number: R-009934

Beerse, Belgium and Leiden, Netherlands - Requisition Number: R-009938

Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

We are searching for the best talent for Associate Director, RA Submissions.

You will be responsible for:

Depending on the project and assigned submission(s), required activities may include, but may not be limited to:

• Develop and maintain a regulatory submission operational strategic plan for assigned products, influencing strategic submission management and publishing considerations for global registration filings.

• Coordinate dossier planning and execution of the global operational submission strategy in alignment with Global Regulatory Team (GRT) and Global Filing and Launch Strategy (GFLS) goals to ensure delivery of initial and major applications through both direct leadership and appropriate delegation.

• Creation and management of complex Dossier Plans for registration submissions, primarily focusing on the US and EU, based on in-depth knowledge and expertise, seeking input from regulatory therapeutic areas, functional area representatives, publishing partners, and key stakeholders. Ensure that all required documents are included in the dossier and perform a review of the published output.

• Act as the Subject Matter Expert (SME) on, and key point of contact for, global registration dossiers for assigned products, providing insights on product dossier plan details, context, and submission history to cross-functional partners and other submission managers executing regional submissions.

• Serve as a member of the Global Regulatory Team (GRT), ensuring the transfer of relevant information between GRT, Submission Working Group (SWG), Global Dossier Team (GDT), and Product Care Team (PCT).

• Maintain effective interactions with relevant partners to ensure identification of risks, priority conflicts, resource issues, and develop mitigation strategies relative to the scope of their responsibilities.

• Ensure relevant submission processes are applied to all submissions, providing guidance to internal and external partners as needed, and coordinate with dossier level publishing partners to achieve production of regulatory submissions that conform to regional and country specific regulatory requirements.

• Monitor the efficiency of submission processes with responsibility for initiating changes within the scope of decision-making authority to minimize inefficiencies and ensure quality.

• Meet regularly with submission collaborators to identify and resolve issues with the quality and delivery of, Dossier Plans, component deliverables, and timelines against established critical metrics.

• Track submission events/activities in appropriate systems/tools.