Regulatory Specialist Ii

Job Overview
Essential Functions
- Acts as a Regulatory Team Leader on more complex projects, which may include technical writing;
- Prepares and/or reviews regulatory documentation in area of expertise, as appropriate;
- Establishes relationships with many customers; may meet face to face without rest of the team to discuss regulatory issues, present lessons learned and discuss customer comments;
- Acts as an SME/ expert in Regulatory knowledge in Chemistry, Manufacturing and Controls/ Lifecycle Maintenance/ Marketing Authorization Transfers/ Labeling/ Publishing as applicable;
- Understands the Scope of Work, deliverables and management of budget for any given project and manages workload as appropriate;
- May give guidance to junior colleagues, including feedback on the quality of technical documents, and may assist in their training and development;
- May present to clients on complex regulatory processes at large full service bid defense meetings...