Regulatory Affairs Project Manager, US Remote Based
Fortrea is seeing a seasoned Project Manager with experience aligned with primary work in regulatory space. This role is accountable for communicating updates and issues to the team members as well as meeting the established timelines. The Regulatory Affairs Project Manager will be responsible for developing and managing budgets, timelines, and quality guidelines for projects, thereby ensuring that expectations are met while identifying and mitigating risks.
Core Responsibilities
- Evaluate the impact of clinical/regulatory changes on assigned projects as well as 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 preapproved 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.
Required Qualifications
- 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.
- Master’s or other advanced degree a plus
- PMP certification a plus
Work Environment
- Work is performed in an office environment with exposure to electrical office equipment.
- Occasional drives to site locations with occasional travel both domestic and international.
Physical Requirements
- Frequently stationary for 6-8 hours per day.
- Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
- Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.
- Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
- Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
- Regular and consistent attendance.
- Varied hours may be required.
Pay Range: USD $115,000-$130,000 / annually
Benefits: All job offers will be based on a candidate’s skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data. Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(K), Paid time off (PTO) or Flexible time off (FTO), Company bonus where applicable.
Application Deadline: June 26,2026
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