Denali Therapeutics is dedicated to developing breakthrough therapies for neurodegenerative disease through our deep commitment to degeneration biology and principles of translational medicine.
The Denali Manager, Regulatory Affairs (Global Regulatory Lead) reporting to an Associate Director, will fill the role of a Global Regulatory Leader accountable for the regulatory leadership of one or more development programs in neurodegenerative diseases. The Manager is accountable for continuously evaluating the regulatory landscape and providing the team guidance to ensure that Denali development programs meet the requirements of global health authorities. The Manager is also accountable for the technical execution of the regulatory strategy, and for representing regulatory affairs in cross-functional teams and with external partners. Denali Regulatory Affairs is dedicated to developing innovative regulatory strategies to facilitate development and approval of novel therapies in neurodegenerative diseases. Denali is seeking candidates with a can-do attitude who operate with the highest integrity, embrace an atmosphere of continuous improvement, and share our commitment to data-driven decision making.
Accountable for developing regulatory strategy for development programs
Leads project teams in implementing and delivering the regulatory strategy
Responsible for identifying regulatory risk and mitigation plans
Accountable for managing Health Authority interactions
Independently executes preparation, submission, and maintenance of regulatory applications, including initial applications, routine amendments, annual reports, IND safety reports, and correspondence with global Health Authorities
Participates in cross-functional teams, providing regulatory feedback and support
Partners with external vendors in support of regulatory document preparation and submission
Maintains up-to-date knowledge of the regulatory landscape, regulations, and guidelines
Complies with relevant governing laws, regulations, guidelines, and Denali SOPs
Bachelor’s degree required. Advanced degree in life sciences strongly preferred.
Average of 4+ years or equivalent relevant experience in regulatory affairs
Broad understanding of international regulations and guidance
Strong experience in IND and CTA filings. NDA/BLA/MAA filing experience preferred.
Excellent written and verbal communication skills
Exceptional influencing, partnership, and collaboration skills
Strong ability to prioritize workload
Well-prepared, competent, and confident when interacting with senior management, health authorities, and internal and external partners
Able to prospectively identify potential problems and to partner effectively and positively to solve issues