Associate Director, Regulatory Affairs Program Management
Janssen Research & Development, L.L.C. is looking to hire an Associate Director, Regulatory Program Manager, to be located in Spring House, PA, Titusville, NJ, Raritan NJ, USA or Beerse, Belgium, Lieden, The Netherlands or Hywycomb, United Kingdom.
The Regulatory Program Manager (RPM) functions as a regulatory submission leader driving projects forward through the translation of regulatory and compound strategy to executable plans and coordination of cross-functional team efforts. The RPM is accountable to both the Global Regulatory Leader and PMO leadership for planning, executing, controlling, and reporting the functional regulatory pathway. This individual provides operational and program management leadership to therapeutic product and platform development programs from approximately phase 2B until all major submissions are completed. RPMs are guided in all matters by our J&J Credo values and our Leadership Performance Standards.
Provide direct line management of department staff as required, empowering the department and teams to deliver the highest possible impact for our programs, business, and patients around the world.
Lead operations with Global Regulatory Team, including management of worldwide submissions, pre and post-submission activities, preparations for health authority meetings and additional major regulatory milestones.
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.
Submission Leader tasked with driving project management of the submission team by setting direction, raising issues, establishing team R&Rs, developing detailed submission plans, and maintaining a close eye on critical path and associated analytics.
Support GRT in a manner that fosters and maintains a high-performance team culture, chairing GRT, Submission Working Group, Rapid Response Team meetings, and similar, as required.
Ensure coordination of critical GRT information and team communications to ensure timely and accurate dissemination of the GRT strategy and operational status throughout the team and between co-development partners and/or other external partners, as required.
Provide global, cross-functional, operational leadership and management to drive risk management, prioritization, and decision-making, challenging the status quo and driving innovation.
Serve as primary PMO point of contact to ensure GRT/CDT functional plans are aligned with compound/program objectives and commitments.
Ensure the development and tracking of key messages and indication specific submission content maximizing the use of the Global Regulatory Strategy Plan and ensuring alignment with overall compound strategy.
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.
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.
A minimum of a Bachelor’s degree is required.
Post-graduate degree in life sciences, business management, regulatory affairs or related field is highly preferred.
Professional project management certification and/or diploma is preferred.
Regulatory certification (RAC) is preferred.
A minimum of 5 years of industry/business experience, including a minimum of three years in pharmaceutical R&D or comparable R&D sector.
Experience in strategic planning, development of regulatory strategy, and cross functional management of global regulatory submissions and processes (e.g. NDA, MAA, and lifecycle documents)
Leadership and management of global submission teams in a matrixed setting, with demonstrated ability to drive and expedite team decision making and translate strategy to clear, executable action plan.
Demonstrated experience conducting business process, scenario, and critical path analysis.
Demonstrated understanding of Global Regulatory Affairs processes
Knowledge of global regulations, guidelines and regulatory requirements
Proficiency in the application of project management standards, planning and visualization tools (MSP experience highly preferred).
Demonstrated ability to resolve controversy and influence teams without formal authority.
Proficiency with Planisware
Experience with clinical trial conduct, Phase I-Phase III.
Proficient in written and spoken English
Minimal local travel between sites
Ability to work virtually
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
United States-New Jersey-Raritan-920 US Highway 202 Other Locations
Europe/Middle East/Africa-Netherlands-South Holland-Leiden, Europe/Middle East/Africa-Belgium-Antwerp-Beerse, Europe/Middle East/Africa-United Kingdom-England-High Wycombe, United States-New Jersey-Titusville, United States-Pennsylvania-Spring House Organization
Janssen Research & Development, LLC (6084) Job Function
R&D Requisition ID
Open Positions from Johnson & Johnson Family of Companies