Description
ICON is seeking a Global Head of Technical Regulatory & Quality (CMC, Quality & MDD) to provide global oversight and leadership to the teams supporting Chemistry, Manufacturing and Control (CMC), Quality and Medical Device & Diagnostic consulting services.
The successful candidate will be responsible for the strategic direction of the Technical regulatory CMC, Quality and MDD function, including driving business development strategies to grow and maintain the business with new and existing clients.
Key responsibilities include:
- Setting the vision and guiding the achievement of goals
- Translating high-level corporate strategy into long-range project plans
- Overseeing the team services in the development and execution of Technical regulatory including Chemistry, Manufacturing and Control (CMC) and MDD development and registration strategies
- Interpreting regulatory guidance in chemistry, pharmaceutical development, specifications, method development, manufacturing and validation
- Serving as the regulatory CMC, Quality & MDD global representative to company executive management
- Leading evaluation of new business opportunities and actively involved in Bid Defense meetings
- Identifying, leading, and sponsoring regulatory technical initiatives
- Embedding continuous improvement strategies for operational execution, quality and productivity gains
- Managing and developing staff including staff professional development and project oversight accountability
The ideal candidate will have:
- Expert understanding of scientific principles and regulatory technical CMC, Quality and MDD requirements
- Expert knowledge of review and approval processes of applicable regulatory Health Authorities / Notified Bodies
- Expertise in pharmaceutical drug and device development, product maintenance and global regulations and operations
- Advanced leadership skills including change management, people development, strategic thinking and influencing
- Ability to manage time and resources required for multiple projects
- Excellent ability to plan, organize and deliver multiple or complex projects
ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.
For more fresh new jobs, check out yubhub.co.