Job Description:

Project Manager, Regulatory Affairs

The 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 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.

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
• Learn more about our core values here!

What we offer:

• Benefits vary by location and may include:

  • Remote working

  • Flexible time off

  • Paid holidays

  • Medical insurance

  • Tuition reimbursement

  • Retirement plans

What we look for:

• Bachelor’s degree in life/health sciences or related discipline, or equivalent required.

• 4 to 6 years of relevant Regulatory experience in a Clinical Research

Organization/Pharmaceutical Company, with a minimum of 2 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.

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.

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