Reg Affairs Spec

Supports the preparation of documentation and submissions under guidance
- Coordinates and manages client deliverables supporting regulatory compliance
- Liaises with internal and external clients in the tracking and status update of project plans and overall support of projects
- Assists with project budgeting/forecasting
- Maintains knowledge and understanding of SOPs, client SOPs/directives, and current regulatory guidelines
- Assists in business development and pricing of projects for the department
- Evaluates client needs in relationship to overall project timelines, quality and delivery
- Engages other project team members, functional units and/or management as necessary to deliver final product, and resolve/mitigate identified issues or barriers to delivery as needed.

Qualifications:
Education and Experience:
Bachelor's degree or equivalent and relevant formal academic / vocational qualification
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to
2+ years).