Senior GCP Compliance Specialist — EU Regulatory Lead

European Medicines Agency; Amsterdam; On-site; EUR 97,000 - 117,000; Full time

Benefits offered by this job

Relocation assistance

Health insurance

Expatriation & education allowances

Job summary

European Medicines Agency in Amsterdam seeks a Senior Scientific Specialist (GCP) to support HCP compliance and regulatory oversight. The role focuses on GCP guideline development, inspections coordination, and collaboration with EU and international partners to ensure patient safety and quality in clinical trials.

The successful candidate will work with the EMA Inspections Office, contributing to strategic initiatives, guidance, and the integration of GCP into the marketing authorisation

Qualifications

• Minimum 5 years in clinical research/GCP relevant work.
• Experience with medicinal regulation or clinical trials oversight.

Responsibilities

• Contribute to/co-ordinate GCP guideline development and input to the GCP Inspectors’ Working Group.
• Provide regulatory support for GCP reviews across life cycle of medicines.
• Coordinate EMA co-ordinated GCP inspections.
• Solicit technical advice on new legislation and regulatory topics.
• Collaborate with EU regulatory groups and international partners on GCP.

Skills

GCP expertise

Guideline development

Communication skills

Inspection coordination

Education

Life Science degree (4+ years)

Job description

European Medicines Agency in Amsterdam seeks a Senior Scientific Specialist (GCP) to support HCP compliance and regulatory oversight. The role focuses on GCP guideline development, inspections coordination, and collaboration with EU and international partners to ensure patient safety and quality in clinical trials.

The successful candidate will work with the EMA Inspections Office, contributing to strategic initiatives, guidance, and the integration of GCP into the marketing authorisation