As a regulatory affairs specialist responsible for authoring, compiling, reviewing, and submitting regulatory submission in compliance with FDA and ICH requirements and according to SOFIE’s project timelines. These submissions include but are not limited to radiopharmaceutical INDs, NDAs, ANDAs, DMFs, Amendments, Supplements, Alerts and Annual Reports. This position will be performed remotely.
List of responsibilities
Responsible for preparation, compilation, review and submission of new NDAs, ANDAs, DMFs, INDs, Amendments, Supplements and Annual Reports for FDA submission
Write related modules in support of regulatory filings as appropriate. Serve as a regulatory subject matter expert to the technical teams to ensure high quality submissions resulting in expeditious approvals from FDA
Work closely with CRO to ensure compliance with FDA submission requirements according to eCTD format and that project timelines are met and delivered
Use critical thinking skills to assist in formulating regulatory strategies in support of submission plan and goals
Represent regulatory affairs in project meetings and provide regulatory guidance to the technical and project teams.
Interact collaboratively with various subject matter experts and functional business units to coordinate authoring and compilation of appropriate regulatory submissions
Review technical documents and provide guidance for accuracy and acceptability for use in FDA submissions.
Follow and become well versed in current FDA and ICH guidelines and current cGMP, cGCP, cGLP and USP requirements related to PET radiopharmaceutical production.
Write SOPS and other documents as needed
Work on special projects as deemed appropriate by Director of Clinical Operations and Chief Scientific Officer
Demonstrates in-depth knowledge and understanding of FDA guidelines
Effectively communicates regulatory requirements and strategies to internal and external partners
Working knowledge of US FDA e-submission requirements
Knowledge/experience with CMC regulatory requirements
Three to five years of regulatory experience
Bachelor’s or Master’s degree in a scientific discipline or equivalent
Strong written and verbal communication skills
Demonstrate knowledge of regulatory requirements for radiopharmaceuticals (preferred)