$170,000 - $185,000 yearly
Arcutis Biotherapeutics Inc
Westlake Village, CA
In support of Arcutis’ development programs, the Associate Director, Regulatory Affairs develops and implements regulatory strategies, assists in the timely preparation, review and submission of documents to regulatory authorities, and maintains compliance with relevant requirements. Roles & Responsibilities Implements strategies for timely submission and approval of pre-clinical submissions, applications for clinical trials, marketing applications, and life cycle maintenance, (e.g. DSUR, Annual Reports, etc.). Provides expertise in translating regulatory requirements into practical, workable plans. Provides regulatory support and guidance to product development teams, project teams, and ex-US development partners. Provides input on key development documents included in INDs and CTA, such as clinical protocols, study reports, investigational brochures. Assists in the planning, preparation and review of submissions to both U.S. and ex-U.S. regulatory agencies...