Denali Therapeutics is hiring : Senior Director, Regulatory Advertising and Promo

Senior Director, Regulatory Advertising and Promotion

Join Denali Therapeutics as the Senior Director, Regulatory Advertising and Promotion.

Overview

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. Denali is committed to delivering meaningful therapeutics to patients.

Location : South San Francisco, CA

Responsibilities

• Developing and implementing regulatory Ad / Promo strategy for a portfolio of investigational and commercial products
• Serving as the Regulatory lead for promotional review committees (PRC / MRC), ensuring timely and compliant review of promotional and external communications
• Interfacing with cross-functional partners including Marketing, Medical Affairs, Legal, Compliance, and Clinical Development to provide strategic regulatory advice on promotional concepts, campaigns, and scientific communications
• Leading and executing FDA pre-submissions and post-submissions related to promotional materials, including advisory comments, 2253 submissions, and correspondence with the FDA OPDP or APLB
• Monitoring and interpreting evolving regulatory landscape, enforcement trends, and Health Authority guidance to proactively assess impact and support business strategy
• Developing internal regulatory policies, procedures, and training programs related to advertising and promotion
• Collaborating with external vendors and consultants to ensure compliance with regulatory promotional requirements
• Contributing to non-project related regulatory initiatives such as internal audits, inspection readiness, and compliance monitoring
• Mentoring and developing regulatory staff, fostering a culture of compliance, collaboration, and continuous improvement
• Upholding Denali’s values of scientific rigor, transparency, and ethical conduct
• Lead direct report(s) through annual goal setting, growth planning, adherence to company policies, maintain training compliance and provide ongoing feedback on growth, development and areas of improvement

Qualifications

Compensation and Benefits

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.

Equal Opportunity

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.

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