About the role

Senior Regulatory Affairs Project Manager leading drug-development projects at Veristat, a global clinical research organization. Coordinating regulatory, clinical, quality, CMC, and business consulting teams.

Responsibilities

Plan, prepare, and execute high quality projects
Provide management and leadership for regulatory affairs projects
Interface with internal departments and company leadership
Interface externally with sponsors and vendors
Integrate consulting activities and assignments across CMC, quality, regulatory, clinical, and business areas
Coordinate work with other teams

Bachelor’s degree in life/health sciences or related discipline, or equivalent required
6 to 8 years of relevant Regulatory experience in a Clinical Research Organization/Pharmaceutical Company
Minimum of 3 years of Project Management or functional team lead experience required
Other professional and/or educational experience may contribute toward this minimum requirement, as determined on a case by case basis
Excellent written and oral communication and interpersonal skills
Strong planning and organizational ability
Good working knowledge of drug development process and regulatory requirements
Familiarity with International Conference on Harmonisation (ICH) guidelines and other applicable regulatory rules and guidelines
Proficiency in English (written and verbal)
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 client, external vendors, and internal team members