Executive Director, Regulatory Science
Orchard Therapeutics
Strategy Manager, Regulatory Program
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)
- Serve 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 submission plans
- Create and own regulatory project plans and develop project and portfolio level reports
- Provide project management support from late development through launch and represent Regulatory Program Management at GRT and PMT
- Translate regulatory strategy into executable regulatory deliverables and work out regulatory scenarios to support decision making
- Support early risk identification and development of mitigation strategies
- Collaborate with Regulatory Leader (GRL), Regulatory Liaisons and Professionals on regional health authority interactions and submissions
- Initiate discussion, establish Global filing plans, verify submission groups, and maintain plans in team SharePoint
- Ensure execution of plans through monitoring progress, assessing critical path, and planning submission roll out
- Coordinate timing of pre-submission activities with Submission Operations
- Act 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 creation and management of regulatory project budgets (OOPs & FTEs)
- Own regulatory tasks in Planisware V6 and MSP S16 schedules and Submission plan in MSP16; create visuals using OnePager, OfficeTimeline, or Swimlane
- Collaborate with CDT Program Management Leader and PMT Program Managers to ensure alignment of strategies and proactively manage scope, time, and cost of regulatory development plan
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
- Experience in regulatory matrix organization is preferred
- 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
- 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
- To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status
