South San Francisco, CA30+ days ago
Key Accountabilities/Core Job Responsibilities: • Developing and implementing regulatory strategy for complex development programs, leading project teams in implementing and delivering the regulatory strategy across multiple programs/indications and/or programs of increasing complexity • Participating in cross-functional teams to provide regulatory feedback and support, proactively assessing and communicating potential risks and mitigation opportunities • Overseeing and directly leading global Health Authority interactions, independently executing preparation, submission, and maintenance of regulatory applications, including initial applications, routine amendments, annual reports, IND safety reports, and correspondence with global Health Authorities • Partnering with external vendors in support of regulatory document preparation and submission • Leading and executing non-project regulatory activities • Maintaining up-to-date knowledge of the regulatory landscape, regulations, and guidelines and for developing thoughtful, data-driven strategies for influencing the regulatory landscape • Complying with relevant governing laws, regulations, guidelines, and Denali SOPs • Recruiting, developing, managing, and mentoring regulatory professionals; contributing to creating a culture of regulatory innovation and excellence; leading direct report(s), if applicable, through annual goal setting, growth planning, adherence to company policies, training compliance and for providing ongoing feedback on growth, development and areas of improvement. The Director, Clinical Regulatory, is accountable for leading and overseeing global Health Authority interactions, project team support, regulatory intelligence activities, and proposing and implementing department initiatives in our drive to defeat neurodegeneration.