Job Description
Regulatory Specialist III
Job Type: Open-Ended Contract
Must reside in one of the following states:
Alabama, Alaska, Arizona, Arkansas, Colorado, Connecticut, Florida, Georgia,
Illinois, Indiana, Iowa, Kansas, Louisiana, Maryland, Michigan, Minnesota,
Missouri, Montana, Nebraska, New Jersey, New York, North Carolina, Ohio,
Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Virginia
Key Responsibilities
+ Support IND/IDE and biologics submissions, including FDA reporting activities
+ Coordinate with IRBs, FDA, investigators, sponsors, and CROs
+ Oversee multi-site clinical trials, ensuring adherence to regulatory timelines and accuracy
+ Prepare and submit:
+ New study protocols, amendments, and continuing reviews
+ Informed consent forms and updates
+ Regulatory reports and essential documentation
+ Ensure compliance with ICH/GCP guidelines, FDA regulations, and AAHRPP sta...
Job Type: Open-Ended Contract
Must reside in one of the following states:
Alabama, Alaska, Arizona, Arkansas, Colorado, Connecticut, Florida, Georgia,
Illinois, Indiana, Iowa, Kansas, Louisiana, Maryland, Michigan, Minnesota,
Missouri, Montana, Nebraska, New Jersey, New York, North Carolina, Ohio,
Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Virginia
Key Responsibilities
+ Support IND/IDE and biologics submissions, including FDA reporting activities
+ Coordinate with IRBs, FDA, investigators, sponsors, and CROs
+ Oversee multi-site clinical trials, ensuring adherence to regulatory timelines and accuracy
+ Prepare and submit:
+ New study protocols, amendments, and continuing reviews
+ Informed consent forms and updates
+ Regulatory reports and essential documentation
+ Ensure compliance with ICH/GCP guidelines, FDA regulations, and AAHRPP sta...