📋 Lead Regulatory Excellence Across APAC from Anywhere in Australia
Join ICON plc as a Senior Manager Regulatory Affairs and take the lead on meaningful regulatory projects across the Asia-Pacific region. This home-based senior role offers the perfect blend of technical leadership, client partnership, and team mentorship, allowing you to shape regulatory strategy while enjoying the flexibility of remote work.
🎯 Your Impact: Key Responsibilities
Regulatory Leadership & Strategy
- Act as technical leader and consultant across diverse regulatory projects
- Provide regulatory submission expertise with deep knowledge of Health Authority processes
- Offer strategic insights to shape submission planning and operational delivery
- Serve as primary liaison between clients and internal project teams
Project Management Excellence
- Lead end-to-end project delivery using best-practice methodologies
- Coordinate project activities and develop/maintain timelines and dashboards
- Deliver financial oversight including budget tracking and accrual reviews
- Ensure seamless communication and trusted client partnerships
Business Development & Mentorship
- Support BD efforts across APAC, contributing to proposals and client development
- Mentor and develop junior colleagues through structured oversight and guidance
- Help junior staff build their business development capabilities
- Delegate tasks with clear direction and support professional growth
⭐ Your Profile: Qualifications & Experience
Essential Requirements
- Solid technical experience in Regulatory Affairs, Clinical, Drug Development, or Project Management
- Strong understanding of regulatory submission pathways and Health Authority processes
- Advanced skills with MS Project, Excel, OnePager, EDMS, and regulatory tools
- Demonstrated project management strengths across planning and stakeholder communication
Technical Expertise
- Experience managing project financials, budgeting, and accruals
- Knowledge of regulatory documentation requirements
- Familiarity with APAC regulatory landscapes
- PMP or similar project management certification highly regarded
Leadership Competencies
- Collaborative mindset with passion for coaching and developing others
- Strong client-facing and communication skills
- Ability to guide teams and manage complex regulatory projects
- Forward-thinking approach to regulatory challenges
💫 Why Join ICON in Australia?
Career Leadership
- Senior role with technical leadership and mentorship responsibilities
- Opportunity to shape regulatory strategy across APAC
- Clear pathway to director-level positions
- Exposure to diverse therapeutic areas and regulatory challenges
Work Flexibility
- Fully home-based position with remote work flexibility
- Competitive compensation package with performance incentives
- Comprehensive health insurance and wellness programs
- Generous vacation entitlements and work-life balance
Professional Impact
- Lead meaningful regulatory projects with global impact
- Develop junior staff and build regulatory capabilities
- Work with leading pharmaceutical and biotech companies
- Contribute to advancing innovative treatments through regulatory excellence
✨ Ready to Lead Regulatory Excellence from Home?
If you're an experienced regulatory professional with strong project management skills and a passion for mentoring others, we encourage you to apply. Join ICON in this senior home-based role and help shape the future of regulatory affairs across the APAC region.
Apply Now & Drive Regulatory Innovation
