Position: Senior Regulatory Affairs Specialist (prepares submissions for ANDAs and/or NDAs)
- Prepare submissions for New Drug Applications (NDAs) according to FDA regulations.
- Develop and assess strategies for regulatory approvals for NDAs by providing input from product development through commercialization.
- Prepare controlled correspondence to FDA.
- Provide technical writing for NDAs, supplements, amendments etc.
- Collect and organize necessary documentation to be included in NDA submissions, reports, etc.
- Prepare the Quality Overall Summary and all eCTD module submission documentation for NDA filings.
- Prepare responses to information requests, amendments, complete response letters, supplements, etc. associated with NDA submission and submit to FDA.
- Review NDA submission documentation to ensure that all current FDA guidelines are met.
- Prepare and maintain a correspondence log for each NDA submission.
- Coordinate eCTD submission of NDA’s between Genus and any outside contracted company.
- Provide regulatory input for the product development and submission process for NDA submissions.
- Prepare annual reports for NDAs in accordance with 21 CFR 314.81.
- Review documents and interact with multiple departments (QA, AS, Engineering, PD, etc.) which provide information and documentation to ensure accurate reporting to FDA.
- Provide a critical detailed review of technical documentation including labeling, distribution reports, analytical procedures, product specifications, manufacturing and packaging batch records, in-process specifications, etc. prior to FDA submission.
- Track NDA commitments made to FDA to ensure commitments are completed and reported in a timely manner.
- Maintain and ensure all NDA documentation is filed properly.
- Maintain and manage product specific checklists to ensure that all required documentation and information is available, accurate and complete for submission.
- Assist in the preparation and submission of required post approval reports such as quarterly and annual periodic adverse drug experience reports, post commitment requirements, etc.
- Maintain current knowledge of FDA regulations and guidance’s pertaining to changes to approved NDA regulatory applications.
- Provide oversight of clinical studies in support of NDA submissions.