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Key Responsibilities:
- Own the end-to-end audit process — scheduling, preparing, conducting, reporting, and following up on routine and directed audits
- Lead a range of audit types across sites, vendors, license partners, and internal processes globally
- Apply deep knowledge of FDA, EU, and ICH regulations to independently resolve GCP compliance issues
Qualifications:
- Bachelor's degree with 6+ years of relevant industry experience including 4+ years direct GCP audit experience
- Experience applying FDA and EU regulations including ICH E6 R3 and applicable standards
- Strong track record of project management, stakeholder management, and collaboration skills
Work Environment:
- Remote work model with flexibility
- Ability to travel 30-40% of the time, domestically and internationally
- Location: Multiple US locations considered
Regeneron
Regeneron is a leading biotechnology company that invents life-changing medicines for people with serious diseases. Founded and led by physician-scientists for over 30 years, we have developed nine FDA-approved treatments and numerous candidates, fostering a culture of innovation recognized as a Great Place to Work.