other
Posted 17 hours agoRegulatory Affairs Project Manager, US Remote
at Fortrea
Remote
Responsibilities
- 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.
- 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
Requirements
- experience aligned with primary work in regulatory space.
- Proactively engage in both quality assurance and risk management activities to ensure project deliverables are met according to both Fortrea and client requirements.
- 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
- Broad knowledge of drug development process and client needs.
- 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.
- 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.
- Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
- 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.
Benefits
- 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.
- benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(K), Paid time off (PTO) or Flexible time off (FTO), Company bonus where applicable.
Additional details
- 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.
- requirements for the conduct of clinical development programs.
- Fluent in local office language and in English, both written and verbal. At least 7 years of
- Occasional drives to site locations with occasional travel both domestic and international. Physical
- Requirements Frequently stationary for 6-8 hours per day.
- Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.
- Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive
- Application Deadline: June 26,2026 #LI-SE1 #remote Learn more about our EEO & Accommodations request here .