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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.
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 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.
• 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.
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 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.
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