Senior Regulatory Affairs Specialist
Medtronic
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 represent Regulatory Program Management at the GRT and PMT
- Create and own regulatory project plans, submission plans, and regulatory schedules in Planisware V6 and MSPS16 (MS Project)
- Develop project and portfolio level reports and visuals (OnePager, OfficeTimeline, Swimlane) to support decision making
- Translate regulatory strategy into realistic and executable regulatory deliverables and work out regulatory scenarios to support decision making
- Support global filings across NA, EMEA, APJLA and manage pre-submission and submission activities
- Monitor regulatory-driven milestones, decision points, critical path activities and inform stakeholders on project status
- Coordinate resource planning and regulatory project budgets (OOPs & FTEs)
- Collaborate with Submission Operations, Regulatory Liaisons, GRL, PMT Program Managers and CDT leaders to ensure alignment and execution
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 (such as 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, now or in the future, sponsorship for employment visa status
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
- Life assurance
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments
- Well-being and work life balance opportunities
- Competitive salary
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory project managementproject planningresource managementregulatory submissionsNDA submissionMAA submissioncross-project analysesregulatory strategy executionregulatory deliverablesregulatory processes
Soft skills
collaborationstakeholder communicationdecision makingorganizational skillsproject coordination
Certifications
Professional project management certificationRegulatory Affairs Certificate
