Senior Regulatory Affairs Associate
The Senior Regulatory Affairs Associate is responsible for handling the regulatory affairs for both internal investigator initiated studies and sponsored studies. The duties will include communications (and submissions to as appropriate) with Cell and Gene Therapy (CAGT) investigators, IRB, other internal agencies. This position will also be responsible for the preparing of submissions to the FDA including new investigator initiated IND studies, as well as study amendments, safety reports and annual IND reports.
- Handle the regulatory affairs for both internal investigator initiated studies and sponsored studies.
- Track and submit renewals of studies. Track the overall status of each study on a study status spreadsheet which can be shared with upper leadership.
- Prepare submissions to the FDA including new investigator initiated IND studies, as well as study amendments, safety reports and annual IND reports.
- Communication with CAGT investigators, including assisting with protocol amendments.
- Responding to IRB requests and submission of new protocols, amendments and renewals.
- Track (and archive per the SOP and version control) and help revised as requested, the preparation of new protocols, as well as protocol amendments. Also, the preparation of renewal reports.
- Draft electronic submissions for new protocols, as well as amendments for various administrative approvals.
- Draft electronic submissions for unanticipated problems.
- Bachelor's degree.
- Four years of relevant experience is required.
- Regulatory Affairs Certification (RAC), Certified Clinical Research Professional (CCRP), Certified Clinical Research Coordinator (CCRC) or Certified IRB Professional (CIP).
- Experience with regulatory affairs, oncology, gene therapy or
Baylor College of Medicine is an Equal Opportunity/Affirmative Action/Equal Access Employer.