[Hiring] Senior Project Manager, Regulatory Affairs @Veristat

Role Description

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.

Qualifications

• 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 clients, external vendors, and internal team members.

Requirements

• Automated Decision Making: All applicants are reviewed by a member of the Veristat Talent Acquisition team; Veristat does not utilize an automated decision-making process.

Benefits

• Remote working
• Flexible time off
• Paid holidays
• Medical insurance
• Tuition reimbursement
• Retirement plans

Company Description

Make an Impact at Veristat! Join a global team with more than 30 years of expertise accelerating life-changing therapies to patients worldwide.

• 105+ approved therapies for marketing applications prepared by Veristat
• 480+ oncology projects in the past 5 years
• 350+ rare disease projects delivered in the past 5 years
• Flexible, inclusive culture — 70% remote workforce, 66% women-led teams