**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Office
- Prepares and reviews regulatory submissions.
- Provides regulatory strategy and/or technical advice to internal and external clients, and acts as a liaison in executing strategies.
- Leads the development and implementation of project-specific processes for sponsors.
- Collaborates with other departments, regulatory consultants, and regulatory authorities.
- Assists in identifying and recognizing out of scope activities in a contract in a timely manner and liaises with other departments to follow through on all aspects of contract modifications.
- Participates in project launch meetings, review meetings and project team meetings.
- Supports business development activities, including project budgeting/forecasting.
- Requires
- Not mandatory but preferred experience clinical trials submissions and development
- Good organizational and planning skills to effectively manage shi...