Regulatory Associate Project Manager

About the role

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.

Responsibilities

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

Requirements

• 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 the 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 experience in project management for IND/CTA and/or marketing application submissions, 505(b)(1) and 505(b)(2)
• Travel up to 20%

Skills

• Excellent organizational, writing, communication, and time management skills needed to manage multiple ongoing projects simultaneously
• Strong understanding of Project Management software, background in SmartSheet preferred

Pay

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.

Benefits

We offer a comprehensive benefits package, which may include health insurance, retirement plans, and paid time off.