Regulatory Affairs Project Manager, US Remote
$115,000–$130,000 year
Remote · United States or Durham, North Carolina, United States
Job Summary
Regulatory Affairs Project Manager responsible for coordinating regulatory submissions and responses, managing budgets and timelines, ensuring quality guidelines, and mitigating risks across clinical development programs. Focus areas include evaluating regulatory changes, preparing submissions to regulatory authorities pre- and post-marketing approval, responding to RFP/RFI, and driving process improvements. Requires knowledge of ICH/GCP, drug development processes, financial controls, and strong project management capabilities. Senior-level role with 7+ years in pharma/regulatory affairs; US-based remote work option and occasional travel. Mastery of cross-functional collaboration and ability to align regulatory activities with client requirements.
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
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