Associate Director, ECO Process Development
Codexis, Inc.
Regulatory Program Strategy Manager
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) and serve as key member of the Project Management Team to align Product and Regulatory strategies
- Provide cross-functional leadership to submission teams to develop and execute submission plans for Global filings (NA, EMEA, APJLA)
- Create and own regulatory project plans and develop project and portfolio level reports using various systems to support decision making
- Provide project management support for regulatory end-to-end process from late development through launch
- Represent Regulatory Program Management at the GRT and PMT and collaborate with GRL, Regulatory Liaisons, Submission Operations, CDT Program Management Leader, and PMT Program Managers
- Translate regulatory strategy into executable regulatory deliverables and develop mitigation strategies via Regulatory Strategy Document and Risk Registry
- Initiate and maintain Global filing plans; verify submission groups; ensure execution through global and regional discussions, risk assessment, monitoring progress and critical path
- Monitor regulatory-driven key milestones, decision points and critical path activities; create reports to inform stakeholders at PMT, GRT and CDT level
- Assist GRTs in determining resource requirements and coordinate creation, maintenance and timely submission of regulatory project budgets (OOPs & FTEs)
- Own regulatory tasks and schedules in Planisware V6 and MSPS16; create visuals using OnePager, OfficeTimeline, or Swimlane
- Proactively plan and manage cross-functional deliverables to support global regulatory strategy and worldwide submissions
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 preferred (e.g., health authority requirements and Global CoPP needs)
- To qualify, applicants must be legally authorized to work in the United States and should not require sponsorship now or in the future
