Director International Regulatory Affairs Planning and Strategy
The Director of Planning and Strategy works in lockstep with the Head of International Regulatory Affairs to drive strategic planning and operations for the function, and to advance the objectives and vision of the Regulatory Leadership. This includes ensuring project support and oversight for complex programs in the region while also coordinating meeting agendas and tracking of required actions until completion. Reviewing internal strategic and operational deliverables, coordination of monthly reporting, resource management, and organizational development will also be in scope. A further key aspect will include seeking key opportunities for cross-functional optimization.
JOB RESPONSIBILITIES:
Serve as a strategic thought partner to the Head, International Regulatory Affairs regarding future initiatives, strategies, project management and organizational efficiency.
Ensure project management support and facilitation of specific projects with the coordination of the preparation of cross-functional meetings and tracking of required deliverables until completion.
Monitor progress toward functional goals, to ensure that the department remains on track to meet or exceed its performance targets.
Contribute to process optimization projects, with a focus on initiatives directed towards productivity, efficiency, effectiveness.
Successfully oversee, lead and deliver operational optimization improvements bringing ideas and visions that can complement the existing infrastructure.
Support the International/EU Regulatory function in management of departmental monthly meetings and agenda development and follow-up on actions.
Take a lead role in the reporting of monthly accomplishments for senior management.
Coordinate functional communications as needed.
Enable enhanced methods of resource management by facilitating planning for headcount needs, both for permanent and for contract staff.
Build and maintain cross-functional interfaces with other key functions and stakeholders (e.g., Commercial, Legal, Government Affairs, HR Partners, GPS, Quality, Clinical Development, etc.).
Prepare presentations for Head of International Regulatory Affairs, covering key communications for the Regeneron Ireland BOD, internal collaborators and external parties as needed.
Experience and Required Skills:
10+ years of industry experience, advanced degree preferred.
A demonstrated ability to drive project execution and to operate independently and proactively to achieve necessary outcomes.
Skilled in a variety of communication modes
An ability to build strong partnerships throughout the organization developing relationships, both formal and informal to help achieve results.
Comfortable operating across all levels of the organization.
Experience in organization models and development would be an advantage.
