Regulatory Associate Project Manager

Premier Research is looking for a Regulatory Associate Project Manager to join our Consulting Leadership team.

You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.

• We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.

• Your ideas influence the way we work, and your voice matters here.

• As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.

Join us and build your future here.

What You'll Be Doing: 

• ​​​Collaborate with cross-functional teams to define contributions for submissions ​

• Manage the preparation and submission delivery of all dossiers and applications to global regulatory authorities to identify and mitigate project risks; revising operational strategies as appropriate to meet key program/project deadlines and objectives ​

• Create project timelines and project plans for submissions (including authoring where applicable) with an understanding of dependencies and critical path analyses to manage the operational aspects of both simple and complex projects from either a global or regional perspective 

• ​Maintain knowledge of the global competitive landscape, regulatory environment, regulations, and guidelines ​

• Work closely the finance team tracking billable hours, milestone delivery, project completion, and close-out​​ 

  

What We Are Searching For:

• ​​Bachelor's degree, or international equivalent from an accredited institution, in a science or health related field

• Preference for candidate located in California

• 2+ years’ experience in of pharmaceutical, device/diagnostics or biotech industry

• ​1-2 years of Regulatory or Project Management experience in a CRO, pharmaceutical, device/diagnostics or biotechnology company with a strong interest in learning more about Regulatory Project Management and working with regulatory health authorities

• Knowledge of the drug development process 

• ​Demonstrated some experience in project management for IND/CTA and/or marketing application submissions, 505(b)(1) and 505(b)(2)  

• ​Excellent organizational, writing, communication and time management skills needed to manage multiple ongoing projects simultaneously

• ​Strong understanding of Project Management software, background in SmartSmeet preferred​

• Travel up to 20%

Premier Research is dedicated to providing compensation that is fair and competitive with market standards. The annualized minimum base pay for this role is $71,000.00 USD. The actual salary will be influenced based on a variety of factors such as the candidate’s qualifications, skills, competencies, and proficiency for the role. We also offer a comprehensive benefits package, which may include health insurance, retirement plans, and paid time off.

Premier Research is proud to be an equal opportunity employer that is compliant with all federal guidelines. All qualified applicants will receive equitable consideration without regard to race, color, religion, sexual orientation, gender identity, national origin, disability or veteran status