Senior Manager, Regulatory CMC

Denali Therapeutics is dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to the genetics and biology of neurodegeneration and biomarker driven development in areas of high unmet medical need.

The Opportunity

In order to support growth, Denali is looking to recruit a Senior Manager for Regulatory CMC. Reporting into the Senior Director of Regulatory CMC, they are responsible for the strategic and technical regulatory leadership of Denali's portfolio of development programs in neurodegenerative diseases. This role is accountable for continuously evaluating the technical regulatory landscape and providing the team guidance to ensure that Denali development programs meet the CMC requirements of global health authorities.

This role is also accountable for the technical execution of the CMC regulatory strategy and for representing CMC 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.

Responsibilities

• Supports investigational new drug applications (IND), ex-US clinical trial applications (CTA), marketing applications (NDA/BLA/MAA), and related correspondence from the US Food and Drug Administration (FDA) and other global regulatory authorities.
• Accountable to develop regulatory strategy and lead the implementation and delivery of the regulatory strategy
• Responsible for identifying regulatory risk and mitigation plans
• Independently executes on preparation, submission, and maintenance of CMC Regulatory application components, including routine amendments, annual reports, and correspondence with global Health Authorities
• Participates in cross-functional teams, providing CMC regulatory feedback and support
• Partners with external vendors in support of CMC regulatory document preparation and submission
• Maintains up-to-date knowledge of the regulatory landscape, regulations, and guidelines
• Leads teams in developing, implementing, and delivering the CMC regulatory strategy for development programs
• Accountable for identifying CMC regulatory risk and mitigation plans
• Accountable for managing Health Authority interactions
• Complies with relevant governing laws, regulations, guidelines, and Denali SOPs

Requirements

• Bachelor's degree required. Advanced degree in life sciences and research experience strongly preferred.
• Experience with small molecule and biologics CMC regulatory development and strategy
• 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 strongly 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

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.

Salary Range: $166,000 to $189,667. 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.

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