Regulatory Affairs Project Manager, US Remote

Fortrea•Durham, CA

5d•$115,000 - $130,000•Remote

About The Position

Fortrea is seeking a seasoned Project Manager with experience in the regulatory space. This role is accountable for communicating updates and issues to team members and meeting established timelines. The Regulatory Affairs Project Manager will be responsible for developing and managing budgets, timelines, and quality guidelines for projects, ensuring expectations are met while identifying and mitigating risks.

Requirements

University/college degree (life science preferred) or certification in a related allied health profession (i.e. nursing, medical or laboratory technology) from an appropriately accredited institution. Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
Understanding of, and ability to determine relevance of, governmental regulatory processes and regulations as pertains to drug regulation.
Detailed knowledge of financial control procedures (i.e. costing systems, time reporting).
Working knowledge of project management processes, especially as it relates to clinical development.
Working knowledge of time and cost estimate development.
Working knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs.
Broad knowledge of drug development process and client needs.
Fluent in local office language and in English, both written and verbal.
At least 7 years of experience in the pharmaceutical industry with 5 years preferably in Regulatory Affairs or in Drug Development.
Demonstrated skills and competency in project management tasks and ability to work independently.
Financial awareness and ability to actively utilize financial tracking systems.

Nice To Haves

Master’s or other advanced degree a plus
PMP certification a plus

Responsibilities

Evaluate the impact of clinical/regulatory changes on assigned projects and Fortrea business operations.
Manage the preparation of high-quality submissions (or parts of submissions) to regulatory authorities pre and post marketing approval within project timelines.
Manage the preparation of high-quality responses to RFP/RFI.
Monitor project schedule and scope to ensure both remain on track.
Implement and follow pre-approved procedures for any deviations.
Proactively engage in both quality assurance and risk management activities to ensure project deliverables are met according to both Fortrea and client requirements.
Propose and implement improvements to enhance the efficiency and the quality of the work performed on assigned projects.
Define and manage project resource needs and establish succession plans for key resources.
Create required project plans.
Implement and monitor progress against project plans and revise as necessary.
Perform other duties as assigned by management.