Strategy Manager, Regulatory Program
ICON plc
Program Strategy Manager – Regulatory
ICON plc
full-time
Posted on:
Origin: • 🇺🇸 United States
Visit company websiteJob Level
Mid-LevelSenior
About the role
- Provide business support to Global Regulatory Affairs (GRA)
- Act as key member of the Project Management Team ensuring product strategy aligns with regulatory strategy
- Provide cross-functional leadership to submission teams to develop and execute global filing plans
- Create and own regulatory project plans and develop project and portfolio level reports using various systems
- Provide project management support for the regulatory end-to-end process from late development through launch
- Represent Regulatory Program Management at the GRT and PMT
- Translate regulatory strategy into realistic, executable regulatory deliverables leveraging the Regulatory Strategy Document and Risk Registry
- Work out regulatory scenarios to support decision-making and support early risk identification and mitigation strategies
- Collaborate with the Regulatory Leader, Regulatory Liaisons and Professionals on Health Authority interactions and submissions across NA-EMEA-APJLA
- Support global filings across all regions; initiate discussions, establish global filing plans and verify submission groups
- Maintain plans in team SharePoint site and ensure execution through global and regional discussions
- Coordinate timing of pre-submission activities with Submission Operations
- Serve as single point of contact for Regulatory Program Management activities and proactively manage cross-functional deliverables
- Monitor regulatory-driven milestones, decision points and critical path activities; create reports for PMT, GRT and CDT
- Assist GRTs in determining resource requirements and coordinate regulatory project budgets (OOPs & FTEs)
- Own regulatory tasks in Planisware V6 and regulatory schedule in MSP S16; own submission plan in MSP S16 and create visuals using OnePager/OfficeTimeline/Swimlane
- Collaborate with CDT Program Management Leader and PMT Program Managers to align regulatory strategy with CDT and functional strategies
- Proactively manage regulatory development plan (scope, time, cost)
Requirements
- 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
- Regulatory experience in Pharmaceutical R&D with NDA/MAA submission experience is a must
- Project management experience in R&D drug development is a must
- Experience in regulatory matrix organization is preferred
- 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 preferred (health authority requirements and Global CoPP needs)
- Legally authorized to work in the United States and not require sponsorship now or in the future
