Job Description:
Project Manager, Regulatory Affairs
The Project Manager, Regulatory Affairs works as an integral part of the global Regulatory Affairs team to support the planning and execution of assigned Regulatory projects, guiding cross functional teams to ensure delivery of high-quality deliverables within agreed timelines. The role works closely with assigned Regulatory Project leads across the full range of Regulatory projects, from small consulting projects to large strategic programs, as necessary with guidance from a Senior PM or line Manager.
The role collaborates internally with colleagues in Medical Writing, CMC and publishing teams, Medical, Quality and PV, business development, finance, other consulting functions, and regulatory leadership, and externally with sponsors, clients, vendors, and contractors.
To fulfil this role, the candidate should have a regulatory background, combined with experience in project management and project governance.
Make an Impact at Veristat!
Veristat Global Regulatory team works across consulting and clinical trial programs from early development to approval and post marketing, in close collaboration with the wider Veristat team.
Join the global Veristat 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 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 or 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 Regulatory Affairs, Drug / Device development, including familiarity with applicable regulatory Regulations 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 clients, 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.
#LI-SI1
Veristat is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
