Senior Project Manager, Regulatory Affairs

Veristat•Quebec, ON

3d•$128,000 - $144,000

About The Position

The Senior Project Manager, Regulatory Affairs provides management and leadership to plan, prepare, and execute high-quality projects. The role interfaces with internal departments and company leadership, as well as external sponsors and vendors. It integrates consulting activities and assignments across CMC, quality, regulatory, clinical, and business areas in coordination with other teams.

Requirements

Bachelor’s degree in life or health sciences or a related discipline, or equivalent.
6 to 8 years of relevant regulatory experience in a Clinical Research Organization or pharmaceutical company, with at least 3 years of project management or functional team lead experience. Other professional or educational experience may contribute toward this minimum on a case-by-case basis.
Excellent written and oral communication and interpersonal skills.
Strong planning and organizational ability.
Good working knowledge of the drug development process and regulatory requirements, including familiarity with International Conference on Harmonisation (ICH) guidelines and other applicable regulatory rules and guidelines.
Proficiency in written and spoken English.
Action-oriented and resilient in a fast-paced environment.
Ability to build effective project teams, motivate others, delegate, and make and implement decisions.
Ability to build and maintain trust and confidence and communicate effectively with clients, external vendors, and internal team members.

Responsibilities

Provide management and leadership to plan, prepare, and execute high-quality projects.
Interface with internal departments and company leadership, and with external sponsors and vendors.
Coordinate consulting activities and assignments across CMC, quality, regulatory, clinical, and business areas with other teams.
Build effective project teams, motivate others, delegate, and make and implement decisions.
Build and maintain trust and confidence, and communicate effectively with clients, external vendors, and internal team members.