Cedent Consulting
Clinical Trial Regulatory Affairs Specialist
Cedent Consulting, Boston, Massachusetts, us, 02298
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.
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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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