Senior Project Manager, Regulatory Affairs
Veristat
Summary
The Senior Project Manager, Regulatory Affairs provides management and leadership to plan, prepare, and execute high quality projects. S/he interfaces with internal departments and company leadership, and externally with sponsors and vendors. The Senior Project Manager, Regulatory Affairs will integrate consulting activities and assignments across all areas of consulting conducted (CMC, quality, regulatory, clinical and business) in coordination with other teams.
Job description
What we look for
- 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, with a 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, as well as strong planning and organizational ability are required.
- Good working knowledge of drug development process and regulatory requirements, including familiarity with International Conference on Harmonisation (ICH) guidelines and other applicable regulatory rules and guidelines.
- Proficiency in English (written and verbal).
- Action-oriented and resilient in a fast-paced environment and will have the 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.
Requirements
- 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
- 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)
- 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 client, external vendors, and internal team members
Benefits
- Remote working
- Flexible time off
- Paid holidays
- Medical insurance
- Tuition reimbursement
- Retirement plans
Company overview
Veristat is a science-first full-service clinical research organization (CRO) and consultancy that specializes in advancing complex and novel therapies through integrated strategic planning, regulatory expertise, and clinical trial execution. With nearly 30 years of experience, the company focuses on supporting emerging, small, and mid-size biopharmaceutical companies in developing innovative treatments for challenging therapeutic areas including oncology, neurology, rare diseases, infectious diseases, and metabolic disorders. Veristat's comprehensive services span the entire drug development lifecycle, from early-phase clinical trial design and execution to regulatory submissions and post-marketing support. The company has established a strong track record in biologics, gene therapies, and cell therapies, having supported the first gene therapy approved in Europe. Operating globally with offices across North America, Europe, and Asia, Veristat employs a team of scientific experts who combine bold thinking with practical execution to help clients navigate regulatory complexities and accelerate the delivery of life-changing therapies to patients in need.