Clinical Regulatory Affairs Associate Job in Columbus, Ohio US
Clinical Regulatory Affairs Associate
Specific Responsibilities: Receive documents from various sources and review for completeness and suitability for submission to FDA. Request and correct missing and/or illegible pages, arrange for translations as needed. Review regulatory documents to assure FDA requirements are met and are ready for submission. Responsible to handle the release and shipment of investigational drug supplies to the investigators participating in the clinical studies. Duties include the compliance with stringent regulations and laws of IND submissions and financial disclosures. Assure CMC and QA have approved the product, and that the labeling of the product meets the regulations for interstate shipment. Handle drug re-supplies for the above-mentioned studies. Prepare 30-day investigator submissions. Gather information and prepare IND and NDA annual reports. With the manager's guidance, prepares new IND, NDA and SNDA submissions, amendments and supplements. Must have the following: Individual will need to be able to organize and prioritize tasks and work independent of manager. Be able to think of new and better ways to accomplish tasks. Direct temporary help in heavy work situations. Work with all team members to accomplish tasks and be able to clearly communicate with the team. Responsible for writing routine FDA submissions. Think of solutions to overcome problems in making submission goals. Review submissions with a critical eye for typos, grammatical errors, pages out of order, etc. Impact of Actions / Decisions -Within functional area: This position is expected to review critical documents and handle routine submissions with little input from the manager. With more complex tasks/submissions, work with the manager to accomplish goals/tasks. - Outside functional area: Work with various functions to resolve any deficiencies. Timely review of critical documents for drug release is expected. Independent Judgment of the adequacy of critical documents such as informed consent forms. Will review the adequacy of reports for completeness, legibility, or the need for translation. About 50% or more of the judgments can/should be made independently by this position. The rest are made with the concurrence or advice of the manager. This position may require the management of temporary labor and supervise the assembly of submission, and verify that the documents meet the regulatory requirements. Education Requirement: Bachelor of Science Degree (biology, chemistry etc. preferred). Equivalency, special qualifications, certifications, licenses, etc. considered Work experience: Up to 3 years of work experience. A basic understanding of scientific disciplines required. Understanding of FDA regulations governing INDs, NDAs, GCPs, submission processes, submission content, and specific time requirements for various submissions desired. Good computer skills required.