Regulatory Associate Project Manager

Premier Research•Regional_CA, CA

5d•Remote

About The Position

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.

Requirements

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

Nice To Haves

Preference for candidate located in California
background in SmartSmeet preferred

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