FierceBiotech and FiercePharma Jobs
Director of Regulatory Affairs - Advantage ONE Executive Search
Aug 08
Location: Bergen County, NJCategories: Director
Position Description
Excellent opportunity to join a young and dynamic biopharma division of an international conglomerate with strong chemical competencies. Company has been developing pharmaceutical capabilities for 15 years and has discovered 3 new compounds now in clinical research and has out-licensed two compounds to big pharma. They are the perfect size, small enough to offer excellent VISIBILITY and a real opportunity to IMPACT the success of the company, but large enough to provide all the resources needed and above average security (not VC funded). Great opportunity to apply your knowledge and experience to design, establish and build a Regulatory Affairs function. If you are weary of all the bureaucracy in big pharma this could be the perfect opportunity for you.
Responsibilities: 1. To prepare, review, assemble, and/or evaluate eCTD format FDA submissions (INDs, NDAs), amendments and supplements, annual reports, and additional documentation, as needed) and assure their accuracy and completeness. 2. Develop and communicate regulatory strategies to other internal departments and external vendors and partners, with the goal of achieving the shortest possible time from project inception to product launch. 3. Responsible for reviewing acceptability of documents for submission, and communicating with other internal departments and external vendors and partners to assure submission timelines are met. 4. Establish and maintain effective communication with FDA regarding review status of submissions and open questions. 5. Maintain and improve a working knowledge of the current regulations and guidance applicable to the manufacture and distribution of CNS drugs for the U.S. Market. 6. Review and proofreading of labeling and labeling comparisons intended for submission to FDA and/or labeling intended for production use. 7. Perform all other duties as assigned, or as business needs require.
Requirements: Advanced degree in a scientific or technical field with 10 years of pharmaceutical regulatory affairs experience; or PhD and 8 years of experience. CNS experience highly preferred. EU regulatory affairs experience would be a plus. Must have knowledge of current regulations related to the filing, approval process, and maintenance of submissions (supplements and annual reports). Knowledge of CMC regulations also required. Must demonstrate a solid understanding of pharmaceutical product development plus FDA regulations and guidelines. Travel: Limited domestic and foreign
Desired: Primary Outcomes: 1. Coordinate submission output to be in line with corporate timelines. 2. Maintain compliance with the Regulatory requirements for CNS drugs for the U.S. Market. 3. Maintain approved NDAs in compliance with FDA regulations; provide appropriate regulatory guidance to other internal departments and external vendors and partners.
