Regulatory Affairs Manager/Sr. Manager
Supervises and participates in the planning, preparing and interpreting regulatory documents for submission to governmental regulatory agencies such as the U.S. Food and Drug Administration. Serves as a liaison with regulatory agencies and contractors, as well as an information source regarding product and assay development questions. Ensures corporate policies and procedures comply with regulatory requirements. Provides accurate and timely regulatory guidance to the R&D, manufacturing, operations and quality staff while maintaining frequent contact with the Senior Director. Responsible for preparation, review, presentation, and evaluation of all FDA submissions to assure accuracy and completeness of submission documents including meeting/briefing packages/ and presentations to the FDA (e.g., pre-IND submission, end-of-phase II, pre-market application, and advisory committee meetings), New Drug Applications (NDAs), Orphan Drug Applications, Market Applications, INDs, (product and Establishment License Applications), and other related documents or CMC section submissions. Determines submission requirements and requests needed data, information, and documentation from pertinent departments, facilities, and affiliates, and from contractors/vendors as needed. Liaises with partner companies as appropriate. Provides signatory approval for reports and amendments to INDs/BLAs, assuring submission within specified regulatory timeframes. Reviews and approves for accuracy and completeness all materials to be included in submissions, including materials prepared by others and supplied to Regulatory Affairs.
Effective written and verbal communication skills. General knowledge of pharmaceutical development and federal regulations in pharmaceutical principles of document management. Excellent program management skills. Proficient in word processing packages. Must be able to represent Biotest Biopharmaceuticals with accuracy and sensitivity to regulatory issues. Detailed knowledge of: Federal Food, Drug and Cosmetic Act; Code of Federal Regulations; FDA guidelines; and Regulatory Affairs department SOPs. Ability to manage junior regulatory staff members
Bachelor’s degree in Pharmaceutical, Biological or Chemical Science or related field. Five plus years plus of practical pharmaceutical development regulatory experience at a management level in Regulatory Affairs with an emphasis on Biologics and BLA submission experience.
