Clinical Trial Regulatory Affairs Specialist

Hybrid role

About the Role

As a Clinical Trial Regulatory Affairs Specialist, you will be responsible for:

• Regulatory Compliance:
Ensuring all clinical trials adhere to applicable regulations and guidelines, including FDA, EMA, and ICH standards

• Documentation Management:
Preparing, reviewing, and submitting regulatory documents, such as Investigational New Drug (IND) applications and Clinical Trial Applications (CTAs).

• Ethics Committee Coordination:
Assisting in the preparation and submission of clinical trial site ethics review board applications and maintaining communication throughout the study.

• Audit Support:
Supporting external regulatory agency audits by providing necessary documentation and regulatory input to minimize potential findings of non-compliance.

This role encompasses a variety of study types, including observational and interventional studies, across all clinical trial phases from Phase 1 to Phase 4.

We offer flexibility for this position to start as a part-time or outsourced role, with the potential to transition into a full-time position based on performance.

What We’re Looking For

•

Experience:

A minimum of 10 years in regulatory affairs within the biotechnology or pharmaceutical industry, with direct involvement in clinical trial regulatory processes.

• Knowledge:
Strong understanding of clinical trial regulations, Good Clinical Practice (GCP), International Council for Harmonisation (ICH) guidelines, and ethical standards.

•

Skills:

Excellent organizational, communication, and interpersonal skills, with a keen attention to detail and strong analytical abilities.

•

Education:

Bachelor’s or master’s degree in regulatory affairs, life sciences, or a related field.