Over the past several years Veristat has contributed to >10% of the approved US marketing applications. Our regulatory team is a highly collaborative, dedicated group of regulatory project managers, US and EU strategists, CMC and publishing and submission experts and led by industry veterans with over 30 years of experience. We are seeking additional team members to lead the complex coordination of preparing NDA/BLA submissions with focus on small/emerging companies.
We believe that our Project Managers are crucial to establishing and building working relationships with our clients as well as cross-functionally within the company. The role provides the opportunity to support and learn from multiple clients and project teams. Veristat offers flexible schedules, a collaborative work environment, and the opportunity to truly make a difference in the lives of patients.
If you are someone who likes having fun while working, loves good humor and appreciates a family environment in your work world, this is the company to be a part of! We are Respectful, Thoughtful, Agile, United & Innovative!
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.
As a Project Manager, Regulatory Affairs You Will...
Manage one or more Regulatory projects from start-up through closeout within approved budgets and timelines.
Proactively recognize changes in scope and work collaboratively with contracts and Sales to develop and ensure timely completion of change orders.
Develop detailed project plans and prioritize tasks to achieve project goals.
Leverage resources, expertise, and knowledge across multiple projects to ensure attainment of project deliverables. Responsible for overseeing production and ensuring the quality and timeliness of project deliverables.
Responsible for effective communication within the project team and with functional management.
Provide regular updates regarding the status and progress of projects.
Act as the key client contact on assigned projects and develop successful working relationships with client to help secure repeat business.
Participate in qualified vendor selection and manage vendor activities.
Coordinate and provide oversight of all elements of the project lifecycle from initial set-up to final invoicing.
Responsible for the identification of project risks and the development and implementation of the mitigations for these risks.
Responsible for ensuring the project is “audit ready” at all times (project team training records, central files, system validation, etc.).
Provide assistance to Sales for capabilities presentations and bid defenses, as required.
Works with Regulatory Affairs leaders to ensure alignment and compliance with local and regional registration requirements as well as with company SOPs and procedures.
Works with Regulatory Affairs staff to ensure the timely submission of client regulatory documents, including pre-IND submissions, INDs, marketing applications, etc.
Attends meetings with scientific advisory groups and regulatory bodies, as needed, to support regulatory submissions on behalf of sponsors.
Participate in department continuous improvement initiatives.
Execute other duties as may be required by the members of the Veristat Management team as training and experience allow.
Strive to consistently uphold Veristat core values.
Experience + Requirements
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.
We help you overcome all the difficult challenges that arise during clinical development, regulatory approval, and post-marketing surveillance.
Veristat is a scientific-minded global clinical research organization (CRO) that will guide you through the complexities of the clinical development and regulatory submission process. We impart strategic decision-making and operational support for your clinical trials and regulatory submission projects by truly creative, innovative, and scientific thinkers. There is no "one size fits all" approach to clinical research. Our teams partner with you to understand your goals to plan and execute your clinical program to achieve success. And, we truly want to make a difference to help you get your medical therapy to market to improve or save people's lives.
In 2020, Veristat teams supported marketing applications for 10% of all FDA Novel Drug Approvals.