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Fortrea

Regulatory Affairs Project Manager

Fortrea

Project Manager overseeing regulatory affairs in the pharmaceutical industry at Fortrea. Managing budgets and ensuring compliance with regulatory guidelines in a remote US position.

Posted 6/18/2026full-timeRemote • 🇺🇸 United StatesSeniorLead💰 $115,000 - $130,000 per yearWebsite

About the role

Key responsibilities & impact
  • 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
  • Monitor project schedule and scope to ensure both remain on track
  • 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 efficiency and quality of the work performed on assigned projects

Requirements

What you’ll need
  • University/college degree (life science preferred) or certification in a related allied health profession (i.e. nursing, medical or laboratory technology)
  • Understanding 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
  • At least 7 years of experience in the pharmaceutical industry with 5 years preferably in Regulatory Affairs or in Drug Development
  • Fluent in local office language and in English, both written and verbal

Benefits

Comp & perks
  • Medical, Dental, Vision, Life, STD/LTD
  • 401(K)
  • Paid time off (PTO) or Flexible time off (FTO)
  • Company bonus where applicable

ATS Keywords

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Hard Skills & Tools
regulatory submissionsquality assurancerisk managementproject managementfinancial control procedurescosting systemstime reportingclinical developmentdrug regulation
Soft Skills
communicationorganizational skillsproactive engagementattention to detail
Certifications
university degreecertification in allied health profession