Director, Regulatory Operations

Denali Therapeutics•South San Francisco, CA

4d•$211,000 - $258,667

About The Position

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 Director of Regulatory Operations is responsible for leading the day-to-day operational execution of regulatory submissions and document management activities in support of Denali’s global development programs. This role ensures regulatory documents and submissions meet internal quality standards and global health authority requirements. The Director will lead a team responsible for publishing, document QC, regulatory systems, and disclosure activities, and will work cross-functionally with Regulatory Affairs, Clinical Development, Technical Operations, and external vendors to support regulatory filings from early development through registration.

Requirements

BS or BA in science/technology or an equivalent combination of education and experience
10+ years of relevant work experience required, including 7+ years of medical writing
Strong working knowledge of regulatory document development standards and best practices.
Advanced skills in the use of MS Word and Smartsheet; experience working in SharePoint and Veeva RIM.
Excellent communication skills and effective in a collaborative team environment.
Ability to work independently and to be innovative in tackling operational challenges.

Responsibilities

Develops and executes on a resource plan (using both internal and external resources) to support medical writing and editing efforts for all Denali-developed regulatory documents
Manages and continuously improves Denali’s regulatory document development process
Supports Development authors to ensure efficient development of high-quality regulatory documents while meeting agreed-to document development timelines.
Manages Smartsheet environment and templated timelines for regulatory documents including reports and dashboards
Establishes and maintains cross-functional relationships in support of program goals; persuades and influences both internal and external stakeholders.
Identifies the need for and leads non-program initiatives and activities.
Supports development and maintenance of regulatory document templates and style guide(s).
Maintains up-to-date knowledge of the regulations and guidelines related to regulatory document structure and content as well as GxP quality standards.
Participates in relevant industry groups