REGULATORY PROGRAM MANAGER

Job Description

Janssen Research & Development, LLC., a Johnson and Johnson Company is seeking a Manager, Regulatory Program Management (RPM) in the Project Management Office (PMO). This position can be located in Springhouse, PA or Raritan, NJ with consideration to alternative locations with the understanding that some travel to Spring House, PA or Raritan, NJ for face-to-face interactions may be required.

The Manager RPM provides Regulatory team support via translating the regulatory strategy into realistic and executable regulatory deliverables with clear assumptions based on GRT input; supporting early risk identification and development of mitigation strategies with team; detail out regulatory scenarios to support decision making in line with Regulatory and CDT strategy; management of the regulatory end-to-end process from entry into late development through launch and post-marketing activities.

The RPM proactively plans and manages the cross-functional project deliverables that support the global regulatory strategy and worldwide submissions (NA – EMEA - APJLA) by working in close collaboration with the Regulatory Liaisons and Professionals to assess NA-EMEA-APJLA specific details on Health Authority interactions and submissions; ensure active follow-up on the progression of all regulatory activities required to successfully and timely complete the regulatory deliverables and monitor regulatory driven key milestones, decision points and critical path activities.

The RPM works in close collaboration with the Regulatory Leader (GRL) to proactively prepare for discussions in the GRT. The role provides cross-functional leadership to the submission teams, including direct management of Modules 1 and 2 and creates project related reports to support decision making at PMT, GRT and CDT level. Additionally, the RPM provides regulatory portfolio oversight, support team member planning of short and long term deliverables and ensure stakeholders are informed on project deliverables status.

The RPM owns the Global Regulatory Affairs (GRA) schedule in V6 via creation, monitoring and maintenance from entry into late development through launch and post-marketing activities. Additionally, with respect to Resource and Budget Management, the RPM coordinates the creation, maintenance, management and timely submission of regulatory project budgets (OOPs & FTEs).

As part of the overall PMO, the RPM supports the Project Management Team by working in close collaboration with the CDT Program Management Leader (CDT-PML) to ensure alignment of the regulatory strategy with the CDT strategy; works in close collaboration with the PMT Program Managers to ensure alignment of functional strategies with the regulatory strategy, proactively manages the regulatory development plan (scope, time, cost) and is the single Point of Contact for “Regulatory Program Management” Activities.

Qualifications

Education:

• B.S. or advanced degree in pharmaceutical-related subject. Professional project management certification is a plus.
• Regulatory certification (RAC) is a plus; Master’s is Regulatory related field is a plus.

Experience:

• 5 years of relevant experience including at least 3-5 years in (bio)pharmaceutical R&D. Experience in global matrix organization is preferred.
• Project management experience in R&D drug development is preferred; Registration experience with global submissions or preparation of dossiers is preferred.
• Demonstrated understanding of Global Regulatory Affairs processes, both pre- and post-marketing. Knowledge of regulations, guidelines and regulatory requirements is preferred
• Operational knowledge of project management

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
United States-New Jersey-Raritan-
Other Locations
Europe/Middle East/Africa-France-Île-de-France-Paris, Europe/Middle East/Africa-Belgium-Antwerp-Beerse, North America-United States-Pennsylvania-Spring House
Organization
Janssen Research & Development, LLC (6084)
Job Function
R&D
Requisition ID
0895190729