The Denali Clinical Regulatory Associate Director, reporting to a Director, is a highly motivated and creative individual with deep and broad regulatory experience and expertise. This individual will fill the role of a Global Regulatory Leader accountable for the strategic and technical regulatory leadership of one or more development programs in neurodegenerative diseases. The Clinical Regulatory Associate Director 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. 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 and implementing regulatory strategy for complex development programs
- Leads project teams in implementing and delivering the regulatory strategy across multiple programs/indications and/or programs of increasing complexity
- Responsible for proactively identifying regulatory risk and mitigation plans in support of clinical development plans
- Accountable for overseeing and directly leading global 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. Proactively assesses and communicates impact, potential risks, and potential mitigations
- Leads and executes non-project regulatory activities
Qualifications and Experience
- Bachelor’s degree required. Advanced degree in life sciences strongly preferred.
- Average of 8+ years or equivalent relevant experience in regulatory affairs
- Thorough understanding of drug development process and the pharmaceutical industry and healthcare environment including regulatory requirements and policy trends
- Strong regulatory experience with INDs/CTAs, NDAs/BLAs/MAAs, lifecycle management, interactions with Health Authorities, developing and implementing regulatory strategies with a proven track record of significant regulatory accomplishments.
- Broad strategic skillset, including creativity and effectiveness in identifying and addressing major strategic challenges (e.g., competitive landscape, challenging therapeutic areas).
- Skilled in influencing, partnership, and collaboration, including demonstrated ability to deliver on goals within a cross-functional team/partnership environment with a high level of professionalism
- Excellent written and verbal communication 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