Director, Regulatory CMC

Neurodegenerative diseases are one of the largest medical challenges of our time. Denali Therapeutics is a biotechnology company dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of translational medicine. Denali is founded on the collaboration of leading scientists, industry experts, and investors who share the vision that scientific discovery energetically applied to translational medicine is the key to delivering effective therapies to patients.

We invite you to consider an opportunity with Denali to help achieve our goal of delivering meaningful therapeutics to patients.

The Denali Regulatory CMC Director, reporting to the Head of Regulatory CMC, is a highly motivated and creative individual with deep and broad regulatory experience and expertise. This individual is accountable for the strategic and technical regulatory leadership of one or more development programs in neurodegenerative diseases. The Regulatory CMC 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.

Key Accountabilities/Core Job Responsibilities:

• Accountable for developing regulatory strategy for both commercial and development programs
• Leads project teams in implementing and delivering the regulatory strategy across multiple programs/indications and/or programs of increasing complexity
• Responsible for identifying regulatory risk and mitigation in support of development plans
• Accountable for overseeing and directly leading global Health Authority interactions
• Independently executes preparation, submission, and correspondence with global Health Authorities for marketing applications, including annual reports as well as initial clinical applications, amendments, 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
• Identifies and maintains leadership/ownership of non-project activities
• When applicable, trains, develops, manages, and mentors junior regulatory professionals and contributes to creating a culture regulatory innovation and excellence
• Complies with relevant governing laws, regulations, guidelines, and Denali SOPs

Qualifications/Skills:

• Average of 10+ years or equivalent relevant experience in regulatory affairs
• Bachelor's degree required. Advanced degree in life sciences strongly preferred.
• Thorough understanding of drug development process and the pharmaceutical industry and healthcare environment including regulatory requirements and policy trends
• Strong 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 skill set, 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 and collaboration skills
• Strong ability to prioritize workload and delegate appropriately
• 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

Salary Range: $204,000.00 to $258,667.00 . Compensation for the role will depend on a number of factors, including a candidate's qualifications, skills, competencies, and experience. Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits. Learn more at https://www.denalitherapeutics.com/careers

This compensation and benefits information is based on Denali's good faith estimate as of the date of publication and may be modified in the future.This compensation and benefits information is based on Denali's good faith estimate as of the date of publication and may be modified in the future.

Denali is committed to its core company value of unity by creating a diverse and inclusive environment. We are proud to be an equal opportunity employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, basis of disability, or any other federal, state, or local protected class.