Clinical Trial Regulatory Affairs Specialist; Boston, MA

Clinical Trial Regulatory Affairs Specialist (Boston, MA)

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.

• 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 Harmonization (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