Senior Regulatory Compliance Expert (FDA-Inspection Preparation) (m/f/d)

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Period 16.03.2026 - 12.07.2026

Location Munich, Germany

Capacity from 95%

Remote up to 100%

Languages

German (Advanced)

English (Advanced)

Industries

Biotechnology Pharmaceutical

Business areas

Quality Assurance

Description

A company is looking for a Senior Regulatory Compliance Expert to support their 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 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 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

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 March 2026 and is planned to end in July 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.

Not available? Can I still benefit from the project?

Yes! Recommend a freelancer for the project and earn 30% of FRATCH's profits every time they get placed — for the duration of that project. Simply share your invite link with a colleague to get started.

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.