Associate Director, RA Submissions
Johnson & Johnson Innovative Medicine is recruiting for Associate Director, RA Submissions. The position can be located on-site/hybrid in the US (Titusville, NJ; Spring House, PA; Raritan, NJ; Horsham, PA; La Jolla, CA) or EMEA (Beerse, Belgium; Allschwil, Switzerland; High Wycombe, United Kingdom; Leiden, Netherlands).
At Johnson & Johnson,?we believe health is everything. Our strength in healthcare innovation empowers us to build a?world where complex diseases are prevented, treated, and cured,?where treatments are smarter and less invasive, and?solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.
For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges.
We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.
At Johnson & Johnson, we all belong.
Key Responsibilities:
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.
