Regulatory Affairs Manager

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

Overview

Co-Founder & Director of Operations at TargED Biopharmaceuticals. TargED is a biotechnology company in Utrecht, the Netherlands, developing first-in-class biological drugs to improve treatment of thrombosis. Lead compound: TGD001, investigated to provide a safe and effective treatment option for a broad range of thrombotic diseases. TargED aims to grow as a clinical company with clinical proof of concept for AIS and iTTP/TMA and to progress programs towards registration.

The regulatory affairs (RA) manager will support regulatory submissions and compliance activities for clinical studies in the European Region and USA, with a focus on preparation of regulatory documents and submissions, including Clinical Trial Applications, substantial amendments, safety updates, and end-of-trial documentation. Part-time engagement (~2 days per week) can be considered with a starting date as soon as reasonably possible.

Responsibilities

• Prepare, compile, and submit clinical trial applications, substantial amendments, and notifications to competent authorities and Ethics Committees via submission portals.
• Prepare and coordinate administrative documentation required for clinical trials.
• Coordinate and submit Development Safety Update Reports (DSURs) and other safety-related reports.
• Analyze and communicate country-specific regulatory guidance and expectations in clinical settings.
• Identify regulatory risks and mitigations in countries participating in the clinical trials.
• Support regulatory compliance databases and systems in the respective countries of TargED clinical trials.
• Establish quality control procedures to assure quality of work on the assigned project.
• Adhere to SOPs and international and local regulations.

Qualifications

• Experience preparing and submitting clinical trial applications, amendments, DSURs, and end-of-trial documents in the European Region and USA.
• Strong knowledge of regulatory requirements, Clinical Trials Regulations, and ICH GCP guidelines for new pharmacological products.
• Scientific background with a Bachelor degree.
• Minimum of 3 years of experience in regulatory affairs, ideally in pharma or biotech.
• Team player with the ability to work in a fast-paced biotech environment.
• Excellent verbal and written communication in English.
• Highly organized with the ability to manage multiple projects and deadlines.
• Strong attention to detail and experience with regulatory compliance databases and systems.
• Available to be in the Utrecht office on a regular basis (Tuesdays and/or Wednesdays).

What can you expect from us?

Compensation includes an attractive salary and a competitive rewards package (fringe benefits such as bonus and equity) in an informal yet professional, international startup environment. You will be encouraged to work independently and to take initiative in a space that offers development opportunities.

How to apply

Applications (motivation and CV) should be addressed to:

Senior Director Regulatory Affairs

E: [e-mail] (copy to: [e-mail])

Applications are due on Monday 15 September 2025.

No unsolicited services or offers please.