Regulatory Program Strategy Manager
ICON plc
Strategy Manager – Regulatory Programs
ICON plc
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 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 to align Product and Regulatory strategy and operationalize 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 using various systems to support decision making
- 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 and executable regulatory deliverables using the Regulatory Strategy Document and Risk Registry
- Support early risk identification and development of mitigation strategies
- Collaborate with Regulatory Leader, Regulatory Liaisons and Professionals for regional Health Authority interactions and submissions (NA/EMEA/APJLA)
- Initiate discussions, establish Global filing plans, verify submission groups, and maintain plans in team SharePoint
- Ensure execution of plans through global and regional discussion, assess requirements and risks, monitor progress and critical path, and plan submission roll out
- Coordinate with Submission Operations for timing of pre-submission activities
- Act as single point of contact for Regulatory Program Management activities and proactively manage cross-functional project deliverables
- Monitor regulatory driven key milestones, decision points and critical path activities
- Create project related reports to support decision making at PMT, GRT and CDT levels and support regulatory portfolio oversight
- Assist GRTs in determining resource requirements using scheduling and resource management tools
- Coordinate creation, maintenance, management and timely submission of regulatory project budgets (OOPs & FTEs)
- Own Regulatory tasks in Planisware V6 and MSP S16 program schedules; create visuals using OnePager, OfficeTimeline, or Swimlane
- Proactively manage the 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 (health authority requirements and Global CoPP needs) is preferred
- To qualify, applicants must be legally authorized to work in the United States and should not require sponsorship now or in the future
Benefits
- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family’s needs
- Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
- Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
- Life assurance
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others
- Inclusive & accessible environment and reasonable accommodations
ATS Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
project managementregulatory strategyrisk managementsubmission planningresource managementproject planningcross-project analysisregulatory processesNDA submissionMAA submission
Soft skills
cross-functional leadershipcommunicationcollaborationproactive managementdecision makingorganizational skillsproblem-solvingstakeholder managementteam coordinationstrategic thinking
Certifications
B.S. in pharmaceutical-related subjectsprofessional project management certificationRegulatory Affairs Certificate
