Associate Director, Clinical Regulatory

Denali Therapeutics•South San Francisco, CA

108d

About The Position

Denali Therapeutics is a biotechnology company focused on developing breakthrough therapies for neurodegenerative diseases. The Associate Director, Clinical Regulatory is a key leadership role responsible for the strategic and technical regulatory direction of development programs. This individual will lead global Health Authority interactions, support project teams, conduct regulatory intelligence, and drive departmental initiatives to combat neurodegeneration.

Requirements

Bachelor’s degree required.
7+ years of relevant work experience required.
6+ years in regulatory affairs required.
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.
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.

Nice To Haves

Advanced degree in life sciences strongly preferred.

Responsibilities

Developing regulatory strategy for complex development programs.
Leading project teams in implementing and delivering regulatory strategy across multiple programs/indications.
Identifying regulatory risk and mitigation strategies for development plans.
Overseeing and directly leading global Health Authority interactions.
Executing preparation, submission, and maintenance of regulatory applications (initial applications, amendments, annual reports, IND safety reports, correspondence).
Participating in cross-functional teams, providing regulatory feedback and support.
Partnering with external vendors for regulatory document preparation and submission.
Maintaining up-to-date knowledge of the regulatory landscape, regulations, and guidelines.
Identifying and leading non-project activities.
Complying with relevant governing laws, regulations, guidelines, and Denali SOPs.
Developing, managing, and mentoring junior regulatory professionals.
Leading direct reports, if applicable, including goal setting, growth planning, policy adherence, training compliance, and providing feedback.