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Senior Regulatory Compliance Expert (FDA Inspection Preparation) (m/f/d)
Project info
- Period23.02.2026 - 21.06.2026
- Capacityfrom 95%
- LocationMunich, Germany
- Languages
- German(Advanced),
- English(Advanced)
- German
- Remoteup to 100%
Description
A company is looking for a Senior Regulatory Compliance Expert to support its team in preparing for FDA inspections. The role includes conducting mock inspections, strategic consulting on inspection readiness, as well as support for pre-approvals and routine inspections. The ideal candidate has extensive expertise in regulatory compliance, especially FDA standards, and plays a key role in ensuring the company meets global compliance requirements.
- Conducting mock inspections according to FDA standards
- Strategic consulting on inspection readiness
- Support for pre-approval and routine inspections
Requirements
- Master’s or PhD in Life Sciences, Pharmacy, Medicine, or Regulatory Affairs
- Former FDA inspector or authority auditor (GCP/GMP/GVP)
- At least 5–10 years of experience in regulatory compliance and audits
- Expertise in global standards (ICH, FDA 21 CFR Parts 11, 210, 211, 312)
- Deep understanding of risk-based audits
- Ability to conduct inspection readiness workshops
- Advising on CAPA plans and data integrity
- Experience with clinical trials, manufacturing site audits, and PV systems
- Knowledge of electronic system compliance