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 the rest of the 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, may seek guidance from ...