Clinical Trial Regulatory Affairs Specialist (Boston, ...

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.

Created: 2026-03-10