Project specification
Period 18.05.2026 - 13.09.2026
Location Munich, Germany
Capacity from 95%
Remote up to 100%
Languages
German(Advanced)
English(Advanced)
Project expertise
Industries
Biotechnology Pharmaceutical
Business 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-approval 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.
- Conduct mock inspections according to FDA standards
- Provide strategic advice on inspection readiness
- Assist with pre-approval and routine inspections
Requirements
- Master’s or PhD in Life Sciences, Pharmacy, Medicine, or Regulatory Affairs
- Former FDA inspector or agency 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
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Frequently asked questions
Where is the project located?
The project is based in Munich, Germany.
What is the duration of the project?
The project preferably starts in May 2026 and is planned to end in September 2026 (4 months).
What is the expected workload for the project?
The project requires a commitment of 95 - 100% capacity (full-time).
What is the remote work policy for the project?
The project offers 0 - 100% remote work.
What language skills are required for the project?
The project requires the following languages: German (Advanced) and English (Advanced).
Which industries is the project related to?
The project is related to the following industries: Biotechnology and Pharmaceutical.
Which business areas does the project cover?
The project covers the following business area: Quality Assurance.
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How to apply for the project?
To apply for the project, click the Apply button on the project page to submit your profile for review. We will forward your resume to the client and get back to you within a few days.
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