Safety Compliance Manager
United Rentals
Regulatory Program Strategy Manager
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) and serve as key member of the Project Management Team
- Ensure product strategy aligns with regulatory strategy and operationalize plans with PMT and GRT
- Provide cross-functional leadership to submission teams developing and executing submission plans for global filings
- Create and own regulatory project plans and develop project and portfolio level reports to support decision making
- Provide project management support for regulatory end-to-end process from late development through launch
- Represent Regulatory Program Management at GRT and PMT and translate regulatory strategy into executable deliverables
- Support early risk identification, mitigation strategies, and regulatory scenarios to inform decisions
- Collaborate with Regulatory Leader, Regulatory Liaisons, Submission Operations and regional teams (NA-EMEA-APJLA) on filings and Health Authority interactions
- Initiate and establish global filing plans, verify submission groups, maintain plans in SharePoint, and ensure execution
- Monitor regulatory-driven milestones, decision points, critical path activities, and inform stakeholders on status
- Assist GRTs with resource requirements, coordinate regulatory budgets (OOPs & FTEs), and manage regulatory development plan (scope, time, cost)
- Own regulatory tasks in Planisware V6 and MS Project (MSPS16), create visuals using OnePager, OfficeTimeline, or Swimlane
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 (e.g., health authority requirements and Global CoPP needs)
- Legally authorized to work in the United States and not require sponsorship
Benefits
- Competitive salary
- 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
- Life assurance
- Flexible country-specific optional benefits (childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others)
- Well-being and work life balance opportunities for you and your family
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
project managementregulatory strategysubmission planningrisk identificationresource managementproject planningtrackingschedulingNDA submissionMAA submission
Soft skills
cross-functional leadershipcollaborationcommunicationdecision makingstakeholder management
Certifications
B.S. in pharmaceutical-related subjectsprofessional project management certificationRegulatory Affairs Certificate
