[Remote] Regulatory Affairs Project Manager, US Remote

Note: The job is a remote job and is open to candidates in USA. Fortrea is seeking a seasoned Project Manager with experience in the regulatory space. This role is accountable for managing budgets, timelines, and quality guidelines for projects while ensuring that expectations are met and risks are identified and mitigated.ResponsibilitiesEvaluate the impact of clinical/regulatory changes on assigned projects as well as Fortrea business operationsManage the preparation of high-quality submissions (or parts of submissions) to regulatory authorities pre and post marketing approval within project timelinesManage the preparation of high-quality responses to RFP/RFIMonitor project schedule and scope to ensure both remain on track. Implement and follow preapproved procedures for any deviationsProactively engage in both quality assurance and risk management activities to ensure project deliverables are met according to both Fortrea and client requirementsPropose and implement improvements to enhance the efficiency and the quality of the work performed on assigned projectsDefine and manage project resource needs and establish succession plans for key resourcesCreate required project plans. Implement and monitor progress against project plans and revise as necessaryPerform other duties as assigned by managementSkillsUniversity/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 requirementsUnderstanding of, and ability to determine relevance of, governmental regulatory processes and regulations as pertains to drug regulationDetailed knowledge of financial control procedures (i.e. costing systems, time reporting)Working knowledge of project management processes, especially as it relates to clinical developmentWorking knowledge of time and cost estimate developmentWorking knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programsBroad knowledge of drug development process and client needsFluent in local office language and in English, both written and verbalAt least 7 years of experience in the pharmaceutical industry with 5 years preferably in Regulatory Affairs or in Drug DevelopmentDemonstrated skills and competency in project management tasks and ability to work independentlyFinancial awareness and ability to actively utilize financial tracking systemsMaster's or other advanced degree a plusPMP certification a plusBenefitsMedicalDentalVisionLifeSTD/LTD401(K)Paid time off (PTO) or Flexible time off (FTO)Company bonus where applicableCompany OverviewFortrea is a provider of comprehensive Phase I through IV clinical trial management, clinical pharmacology, patient access solutions. It was founded in 2023, and is headquartered in Durham, North Carolina, USA, with a workforce of 10001+ employees. Its website is https://www.fortrea.com.Company H1B SponsorshipFortrea has a track record of offering H1B sponsorships, with 6 in 2026, 14 in 2025, 25 in 2024, 6 in 2023. Please note that this does not guarantee sponsorship for this specific role.