Project specification
Period 01.06.2026 - 27.09.2026
Location Munich, Germany
Capacity from 95%
Remote up to 100%
Languages
German (Advanced)
English (Advanced)
Project expertise
Industries
Biotechnology Pharmaceutical
Areas
Quality Assurance
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, providing strategic advice on inspection readiness, and assisting with pre-approvals and routine inspections. The ideal candidate has extensive knowledge of regulatory requirements, especially FDA standards, and plays a key role in ensuring the company meets global compliance requirements.
- Conducting mock inspections according to FDA standards
- Strategic advice on inspection readiness
- Support for pre-approval and routine inspections
Requirements
- Master’s degree 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
- Consulting on CAPA plans and data integrity
- Experience with clinical trials, manufacturing site audits, and PV systems
- Knowledge of electronic system compliance
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Frequently asked questions
The project is based in Munich, Germany.
The project preferably starts in June 2026 and is planned to end in September 2026 (3 months).
The project requires a commitment of 95 - 100% capacity (full-time).
The project offers 0 - 100% remote work.
The project requires the following languages: German (Advanced) and English (Advanced).
The project is related to the following industries: Biotechnology and Pharmaceutical.
The project covers the following business area: Quality Assurance.
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