Senior Analyst, Regulatory Program Management – Immunology

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 jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world.  We provide an inclusive work environment where each person is considered as an individual.  At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

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):

Belgium R-108825, Ireland R-108828, Netherlands R-108829, Switzerland R-108826, United Kingdom R-108827, United States of America R-104909

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

• Serve as key facilitator within the RPM department to assigned service area to help ensure proper visibility to book of work, monitoring quality and process to support the success of the RPM department.
• Function as a change management and implementation leader for new process and system rollout across RPM team.
• Where assigned, lead operations with Global Regulatory Team (GRT), including activities such as ensuring visibility to and/or management of health authority meeting planning, worldwide submissions, driving processes to optimize global filing and launch strategy, and key deliverable in early and late development stages including consolidation of regulatory strategy, pre- and post-submission activities and preparation for health authority meetings.
• Translate regulatory requirements and strategy into an executable plan at a level of detail that allows teams to understand what is critical at any one time, proactively identify and mitigate risks, and exploit meaningful opportunities for acceleration. (e.g., MSP project plan, risk and opportunity playbooks, scenario evaluation and business case development).
• Provide strong operational leadership to Regulatory and program teams, providing scenario and visualization support driving rapid and informed decision making, challenging status quo, and fostering impactful innovation.
• Support the Global Regulatory Team (GRT) in a manner that fosters and maintains a high-performance team culture, facilitating GRT, Submission Working Group, Rapid Response Team meetings, and similar as required.
• Ensure coordination of critical regulatory information and team communications to ensure timely and accurate dissemination of the GRT strategy and operational status throughout the team including co-development partners and/or other external partners, as required.
• Lead the operational execution of select marketing applications including clinical variations and Pediatric submissions, partnering to ensure alignment of Regulatory and compound submission strategies, developing clear and detailed plans, ensuring team roles, responsibilities and accountabilities, and positioning teams to proactively mitigate risks and enhance opportunities.
• Drive process improvements and embed best practices from across programs, TA’s and functions into supported teams.
• Work across functions and organizational boundaries to establish processes and procedures and new innovative methods that improve overall delivery.
• Build RPM value proposition through continuous refinement of delivery, prioritizing and focusing on areas of highest impact and opportunity, and actively leading efforts to enable enhanced capabilities and impacts.
• As required, work with standard budgeting and forecasting process and reporting tools to build and maintain the regulatory components and health authority budget to an overall coordinated project plan in Planisware.
• Support and facilitate activity, resource and cost planning across the R&D project portfolio, as required. 
  
  

We are searching for the best talent for a Senior Analyst, Regulatory Program Management – Immunology. This position can be located in Spring House, PA; Horsham, PA; Titusville, NJ; Raritan, NJ; Cambridge, MA; La Jolla, CA; Beerse, Belgium; Leiden, Netherlands; Maidenhead, UK; Basel, Switzerland; or Cork, Ireland.

Candidates must already have authorization to work in the country of employment. Immigration sponsorship and relocation support are not available for this position. Candidates authorized to work pursuant to a short-term status (e.g., F-1) who require future immigration sponsorship are not eligible.