Responsible for long- and short-term planning and directing of regulatory activities. Ensures that corporate policies and clinical programs are aligned with rules and regulations governing the development of pharmaceuticals. Develops and implements strategies for the earliest possible approval of regulatory applications. Advises and manages regulatory consultants and reviews ongoing projects. Negotiates with national and international agencies, as needed, to resolve key regulatory issues and expedite approvals of products. Reviews and prepares responses to inquiries from regulatory authorities. Monitors national and international registration requirements through review of publications, seminars, and direct communication with external regulatory personnel. Communicates pertinent changes and updates and provides general regulatory guidance to project teams and staff. Reviews technical and clinical documentation, coordinates the target product profile and drafts product labeling. Oversees the preparation, review and submission of investigational and marketing applications, including routine reports/renewals, supplements and amendments as required by internal department (Regulatory, Preclinical, CMC, Clinical, etc.) to update regulatory information and ensure compliance with the Food and Drug Administration (FDA) and international regulations/ interpretations. Works with clinical R&D to strategize late phase clinical development plans in order to ensure successful global regulatory submissions and desirable product labels. Researches and analyzes regulatory information and determines acceptability of data, procedures, and other documentation presented in support of product registration.
Provides input on budget requirements and monitors project and program costs. Is responsible for managing and accomplishing annual regulatory departmental goals. May hire, train and develop regulatory staff and provide input on associated compensation and department structure decisions. Performs other related duties as required and assigned.
• Minimum PhD and minimum 12 years, including regulatory affairs experience in the development of pharmaceutical products for U.S. and International approval. • In-depth knowledge of FDA laws. History of positive interactions with the FDA and International regulatory bodies. • A background in CNS drug development is desirable but not required. • History of NDA submission(s) and label negation(s)
Dart NeuroScience LLC (DNS) is a privately held company with offices in San Diego, CA.
DNS is a company discovering new technologies and developing new therapies to help maintain cognitive vitality throughout life. DNS's mission is to become the leading specialized pharmaceutical company for memory disorders by focusing on the discovery and development of innovative drugs with new mechanisms o...f action. These discoveries are firmly based in a careful examination of the genes involved in the reorganization of synaptic connections in the brain, a cellular/molecular process which underlies both implicit (motor skills) and explicit (facts and events) forms of memory.
Our unique company culture engages employees by promoting thought-provoking investigation and targeted research opportunities. Our collegial environment also recognizes the value of stimulating cross-functional communication and collaboration as catalysts in generating the creative spark that inspires novel approaches and produces ground-breaking results. We want to attract, retain, and reward the top talent in our field. If you are looking for a productive, meaningful career path in the area of neuroscience, we would like to hear from you!