Job Overview Prepares and/or reviews regulatory submissions to support clinical trial and marketing authorisation activities for either internal and/or external clients. Independently provides regulatory support for more complex projects.
Essential Functions - Acts as a Regulatory Team Leader on complex projects, which may include technical writing and/or may act as a Project Manager for a stand‑alone project, with guidance from senior staff as appropriate.
- Competently writes regulatory and/or technical documents with minimal review by senior staff.
- Establishes relationships with many customers; may meet face to face without rest of team to discuss regulatory issues and present lessons learned. Adopts a proactive and flexible approach to resolve any issues.
- Undertakes detailed review and management of budgets related to projects, including out of scope activities. Ensures revenue is recognised and challenges when appropriate,...