Associate Director, Clinical Regulatory

Role Summary

The Associate Director, Clinical Regulatory is a highly motivated and creative individual with deep and broad regulatory experience and expertise. This individual is a Global Regulatory Leader accountable for the strategic and technical regulatory leadership of one or more development programs in neurodegenerative diseases. This leader 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.

Responsibilities

• Accountable for developing 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 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 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
• Identifies and maintains leadership/ownership of non-project activities
• Complies with relevant governing laws, regulations, guidelines, and Denali SOPs
• Develops, manages, and mentors junior regulatory professionals and contributes to creating a culture regulatory innovation and excellence; leads direct report(s), if applicable, through annual goal setting, growth planning, adherence to company policies, maintains training compliance and provides ongoing feedback on growth, development and areas of improvement

Qualifications

• Required: Bachelor’s degree
• Preferred: Advanced degree in life sciences
• Required: 7+ years of relevant work experience, including 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
• Required: 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
• Required: Broad strategic skill set, including creativity and effectiveness in identifying and addressing major strategic challenges (e.g., competitive landscape, challenging therapeutic areas)
• Required: 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
• Required: Excellent written and verbal communication and collaboration skills
• Required: Strong ability to prioritize workload and delegate appropriately
• Required: Well-prepared, competent, and confident when interacting with senior management, health authorities, and internal and external partners
• Required: Able to prospectively identify potential problems and to partner effectively and positively to solve issues

Skills

• Regulatory strategy development
• Global Health Authority interactions
• Regulatory submissions (INDs/CTAs, NDAs/BLAs/MAAs) and lifecycle management
• Regulatory intelligence and policy interpretation
• Cross-functional collaboration and leadership
• Vendor management
• Strategic thinking and problem solving
• Strong written and verbal communication

Education

• Bachelor’s degree in life sciences or a related field
• Advanced degree in life sciences strongly preferred