Biotech Regulatory Affairs Manager — Clinical Trials (EU/US)

TargED Biopharmaceuticals; Utrecht; Hybrid; EUR 60,000 - 80,000; Part time

Benefits offered by this job

Attractive salary

Competitive rewards package

Development opportunities

Job summary

A biotechnology firm in Utrecht is seeking a Regulatory Affairs Manager to support regulatory submissions and compliance activities for clinical studies. The ideal candidate will have at least 3 years of experience in regulatory affairs, particularly within the pharma or biotech industry, and must be knowledgeable about regulatory requirements and clinical trials. This part-time position offers attractive compensation and development opportunities.

Qualifications

• Minimum of 3 years of experience in regulatory affairs, ideally in pharma or biotech.
• Strong knowledge of regulatory requirements, Clinical Trials Regulations, and ICH GCP guidelines.
• Excellent verbal and written communication in English.

Responsibilities

• Prepare and submit clinical trial applications and safety-related reports.
• Analyze country-specific regulatory guidance.
• Establish quality control procedures and adhere to SOPs.

Skills

Regulatory compliance

Clinical trial applications

Team collaboration

Communication skills

Attention to detail

Education

Bachelor degree in a relevant field

Tools

Regulatory compliance databases

Job description

A biotechnology firm in Utrecht is seeking a Regulatory Affairs Manager to support regulatory submissions and compliance activities for clinical studies. The ideal candidate will have at least 3 years of experience in regulatory affairs, particularly within the pharma or biotech industry, and must be knowledgeable about regulatory requirements and clinical trials. This part-time position offers attractive compensation and development opportunities.