Hiring Company: Dart NeuroScience
Job Code: 17-055 #812885
Location: San Diego, CA
Job Type: Full Time
Description: Job Summary:
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)