Reg Affairs Spec

Job Description

- 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 qualificationPrevious experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years).