Regulatory Program Management - Sponsor Dedicated

The RPM will provide business support to GRA. Key member of the Project Management Team ensuring the Product strategy aligns with the Regulatory strategy and works in concert with the PMT and GRT to operationalize the plans. Provides cross-functional leadership to the submission teams in developing and executing the submission plans for Global filings. Creates and owns the regulatory project plans and develops project and portfolio level reports utilizing various systems to support key decision making.

Deliverables:

• Will provide project management support for the regulatory end-to-end process from entry into late development through launch.
• Will represent “Regulatory Program Management” at the GRT.
• Translate regulatory strategy into realistic and executable regulatory deliverables with clear assumptions based on GRT input through leveraging of the Regulatory Strategy Document and Risk Registry.
• 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.
• Support Global filings across all regions; Initiate discussion, establish the Global filing plan and verify submission groups; maintain appropriate plans in the team Sharepoint site; ensure execution of the plans through discussion at the global and regional levels, assessing requirements and risks, monitoring progress and assessing critical path, and planning for submission roll out based on priorities.
• Works in close collaboration with Submission Operations for timing of pre-submission activities.
• Is single Point of Contact for “Regulatory Program Management” activities.
• 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, etc.).
• Monitors regulatory driven key milestones, decision points and critical path activities.
• Creates project related reports to support decision making at PMT, GRT and CDT level, supports regulatory portfolio oversight, supports team member planning of short- and long-term deliverables.
• Informs stakeholders on project deliverables status.
• Assists GRT’s in determining resource requirements utilizing scheduling and resource management tools to support early and late development teams, depending on TA and R&D needs.
• Coordinates the creation, maintenance, management and timely submission of regulatory project budgets (OOPs & FTEs).
• Owns the Regulatory tasks in the Planisware platform V6 program schedule; responsible for the creation, monitoring and maintenance.
• Owns the Regulatory schedule in MSPS16; responsible for the creation, monitoring and maintenance of the timelines. Depending on program plans this activity can start as early as Phase I Health Authority Interactions and extends through Initial Filings and into subsequent add-on submissions.
• Owns the Submission plan in MSP 16; creation, monitoring and maintenance.
• Creates visuals utilizing OnePager, OfficeTimeline, or Swimlane.
• 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.

Profile:

• B.S. or advanced degree in pharmaceutical-related subjects.
• Professional project management certification is a plus.
• Regulatory Affairs Certificate is a plus.
• 5 years of relevant experience including at least 3-5 years in (bio)pharmaceutical R&D.
• Experience in big matrix organization is preferred.
• The key requirement is strong program-level experience, particularly in managing trials and studies at the compound level.
• Project management experience in R&D drug development is a must.
• Detailed knowledge of: project planning, tracking, resource management, project planning and scheduling tools, and cross-project analyses.
• Registration experience with global submissions pre and post marketing is preferred.
• Understanding of Regulatory processes, both pre- and post-marketing.
• Working knowledge of regulations, guidelines and regulatory requirements is preferred; such as health authority requirements and Global CoPP needs.