Senior Director, Regulatory Advertising and Promotion Job at Denali Therapeutics

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 Bachelor’s degree required; advanced degree in life sciences or relevant discipline strongly preferred 12+ years of regulatory affairs experience in the biotechnology or pharmaceutical industry, with at least 8+ years specifically in regulatory advertising and promotion Prior experience leading promotional review for marketed products and late-stage pipeline assets Expert knowledge of FDA advertising and promotion regulations, including 21 CFR 202.1, FD&C Act, and applicable guidance documents (e.g., promotional labeling, social media, disease awareness) Demonstrated experience in direct engagement with FDA OPDP or APLB Strategic thinker with a strong understanding of the commercial landscape, scientific communication, and risk-based decision-making Excellent written and verbal communication skills, including the ability to influence across all levels of the organization Proven leadership experience in building, managing, and mentoring regulatory teams Exceptional organizational skills and ability to manage multiple priorities in a dynamic environment High level of integrity, professionalism, and attention to detail 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. #J-18808-Ljbffr