Cedentinc
Clinical Trial Regulatory Affairs Specialist (Boston, MA)
Cedentinc, Boston, Massachusetts, us, 02298
Clinical Trial Regulatory Affairs Specialist (Boston, MA) Hybrid role
Please ensure you read the below overview and requirements for this employment opportunity completely. 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. 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.
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Please ensure you read the below overview and requirements for this employment opportunity completely. 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. 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.
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