Manager, Regulatory Program Management
Janssen Research & Development, L.L.C. is looking to hire a Manager, Regulatory Program Manager, to be located in Beerse, Belgium; Netherlands or Switzerland.The RPM is accountable to both the Global Regulatory Leader and the PMO leadership for planning, executing, controlling, and reporting the functional regulatory path in line with regulatory and compound strategy. The individual is a regulatory submission leader who drives project management activities through the coordination of cross-functional teams. They are key to providing cross-functional operational and program management leadership for the development of therapeutic products or non-interventional healthcare platforms in a global, cross-functional organization, from entry, late development, through to completion of major lifecycle extensions. RPMs are guided in all matters by our J&J Credo values and our Leadership Performance Standards.
•Translate the CDT/GRT strategy to functional plans with goals & objectives in alignment with therapeutic and program objectives. Provide context and history to new GRT members/partners. Utilize and embed GRA processes and tool to lead team and facilitate work.•Provide outstanding global cross-functional operational leadership and management to drive risk management, prioritization, and decision-making—the RPM challenges the status quo and leads innovation.•Coordinate GRT information, documentation, 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 the need arises).•Steer GRT in a manner that fosters and maintains a high-performance team culture; As delegated, chair the GRT, Submission Working Group, Rapid Response Team meetings, and lead operations for regulatory, such as, management of Worldwide submissions, preparations for Health Authority meetings and other regulatory achievements.•Submission Lead tasked with driving the project management of the submission team by setting direction, raising issues, establishing project management team R&R, developing detailed submission plans in appropriate planning tool, such as MSP, that encompass coordinated WW submission strategies, maps pre and post-submission activities, handles delivery of regulatory components of submissions, maintaining a close eye on critical path and associated analytics to assess acceleration potential. •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.•Ensure the development and tracking of key messages and indication specific submission content maximizing the use of the Global Regulatory Strategy Plan. •Challenge innovation, make it safe to try unique approaches, and take prudent risks. Mentor the team to bounce back quickly from disappointments and learn from mistakes. Drive process improvements across the functions. Self-accountable for the GRT’s and PMT submission team performance. Contribute to the success of the PMO in achieving its goals & objectives by ensuring program work is conducted in compliance with PMO processes and Company policies, lead program management process & quality improvement initiatives and other tasks assigned by the leadership team.•Individual leadership: empower colleagues through personal example, and dedication to team goals. Instill confidence and build group trust. Use emotional intelligence to spot signals others miss. Keep group focused on strategy and goals despite complexity or controversy. Liaise between organizations. A collaborative mind-set and a love for working across multiple teams; turn adversity into opportunities for change and growth. Makes authoritative decisions when required•Works with other R&D departments to establish processes and procedures that facilitate activity, resource and cost planning across the R&D project portfolio.QualificationsEducation:
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. Regulatory certification (RAC) is preferred. Professional project management certification and/or diploma is preferred.Experience and Skills:
- Over 5 years of proven experience in regulatory including at least 3-5 years in clinical development/(bio)pharmaceutical R&D.
- Experience in early strategic planning and cross functional management of global regulatory submissions and processes, both pre- and post-marketing (e.g. NDA, MAA, and lifecycle documents etc.) is required.
- Knowledge of global regulations, guidelines and regulatory requirements is required.
- Proficient in the application of project management standards and tools.
- Prior experience as a member of a cross-functional team is required.
- Demonstrated ability to resolve controversy and influence teams without formal authority is required.
- Successful experience managing and leading global and/or virtual teams is preferred, especially if done within a multi-disciplinary organization.
- Experience in planning and management of IND/CTA’s.
- Proficient in Microsoft Project, Planisware, and visualization tools.
- 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.Primary Location
Janssen Pharmaceutica N.V. (7555)Job Function
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