Reg Affairs Spec

Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

Job Description

- 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 shifting priorities

• Capable of working effectively on a team and/or independently with minimal supervision

• Good electronic document production skills

• Good proficiency in several computer applications including Microsoft Office software

• Good attention to detail and quality of documentation

• Good interpersonal skills with the ability to interact with customers

• Solid verbal and written communication skills

• Capable of multitasking and managing multiple projects