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Beerse, BE

Associate Director, Regulatory Program Manager (RPM)-00000968

Description

Position Overview:

Global Regulatory Team Support:

- Represents "Regulatory Program Management" at the GRT
- Translates the regulatory strategy into realistic and executable regulatory deliverables with clear assumptions based on GRT input
- Works out regulatory scenarios to support decision making in line with Regulatory and CDT strategy
- Supports early risk identification and development of mitigation strategies
- Works in close collaboration with the Regulatory Leader (GRL) to proactively prepare regulatory activities to be discussed in the GRT
- Works in close collaboration with the Regulatory Liaisons and Professionals to work out NA-EMEA-APJLA specific details on Health Authority interactions and submissions
- Works in close collaboration with Submission Operations at timings of pre-submission activities
- Is single Point of Contact for "Regulatory Program Management" Activities

Schedule Management:

- Manages the regulatory end-to-end process from entry into late development through launch with or without the support of the Critical Phase Program Management Group
- Owns the Global Regulatory Affairs (GRA) schedule in P5; creation, monitoring and maintenance.
- Proactively plans and manages the cross-functional project deliverables that support the global regulatory strategy and worldwide submissions (NA - EMEA - APJLA):
- Active follow-up on the progression of all regulatory activities required to successfully and timely complete the regulatory deliverables (Health Authorities interactions, submissions ....)
- Monitors regulatory driven key milestones, decision points and critical path activities

- Provides cross-functional leadership to the submission teams in executing the Accelerando finalized pre-submission plan, including direct management of Modules 1 and 2
- Creates project related reports to :
- support decision making at PMT, GRT and CDT level
- provide regulatory portfolio oversight
- support team member planning of short and long term deliverables
- inform stakeholders on project deliverables status

Resource- and Budget Management:

- Coordinates the creation, maintenance, management and timely submission of regulatory project budgets (OOPs & FTEs)

Project Management Team Support:

- Represents "Regulatory Program Management" at the PMT
- Works 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)
- Is single Point of Contact for "Regulatory Program Management" Activities

Critical Phase PM Group Support:

- Partners with Critical Phase Program Management Group, if needed for mapping critical submissions in detail
- Ensures implementation and monitoring of critical submission activities in line with the Accelerando concepts
- Partners with Critical Phase Program Management Group in lessons learned exercise post-submission

Primary Duties:

- Work with regulatory project team on regulatory strategy to move to next stage gate (including scenario planning)
- PM support to GRT
- Bridges GRT and PMT by dual membership and active engagement

- Map and manage execution of regulatory activities and submission packages (Phase 2, end of Phase 2, Requests for guidance, CTD, etc.)
- Create and manage regulatory plan in P5
- Maintain regulatory schedules, resources and budget in coordination with GRA, as needed
- Drive execution of regulatory activities, working to mitigate risks

- Participate as core member of global submission team and global dossier team, includes development of global submission plan (in P5)

Qualifications


Education:

- B.S. or more advanced degree in pharmaceutical-related subject. Professional project management certification is a plus.

Experience:

- 7+ years of relevant experience including at least 3 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

Critical Competencies

- Change Leadership
- Interdependent Partnering
- Innovation
- Results Driven
- Project Team Management and Development

Travel: Up to 15%

Primary Location:Europe/Middle East/Africa-Belgium-Antwerp-Beerse
Organization: Janssen Pharmaceutica N.V. (7555)
Travel:Yes, 10% of the time
Job Function: Regulatory Affairs