Regulatory Program Strategy Manager
ICON plc
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)
- Key member of the Project Management Team ensuring Product strategy aligns with Regulatory strategy and operationalizes plans with PMT and GRT
- Provide cross-functional leadership to submission teams in developing and executing submission plans for Global filings
- Create and own regulatory project plans and develop project and portfolio level reports utilizing various systems to support key decision making
- Provide project management support for regulatory end-to-end process from entry into late development through launch
- Represent “Regulatory Program Management” at the GRT and PMT
- Translate regulatory strategy into realistic and executable regulatory deliverables using Regulatory Strategy Document and Risk Registry
- Support early risk identification and development of mitigation strategies
- Collaborate with Regulatory Leader (GRL), Regulatory Liaisons and Professionals for Health Authority interactions and submissions across NAEMEA-APJLA
- Initiate discussion, establish Global filing plan, verify submission groups, maintain plans in team Sharepoint, ensure execution through global/regional discussions
- Work with Submission Operations for timing of pre-submission activities
- Proactively plan and manage cross-functional project deliverables supporting global regulatory strategy and worldwide submissions
- Monitor regulatory driven key milestones, decision points and critical path activities
- Create project related reports to support decision making at PMT, GRT and CDT level
- Assist GRTs in determining resource requirements and coordinate creation/maintenance of regulatory project budgets (OOPs & FTEs)
- Own Regulatory tasks in Planisware V6 and Regulatory schedule and Submission plan in MSPS16; create visuals using OnePager, OfficeTimeline, or Swimlane
- 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
- 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
