Executive Director, Regulatory Affairs, Advertising and Promotion

Responsibilities

• Develop and lead global regulatory strategy for advertising and promotion across all products and therapeutic areas.
• Establish and maintain policies, procedures, and governance frameworks for promotional review and approval processes.
• Serve as the regulatory lead for promotional compliance, ensuring alignment with FDA OPDP, EMA, and other global regulatory expectations.
• Provide strategic guidance on product positioning, messaging, and differentiation while ensuring compliance with labeling and regulatory standards.
• Oversee review and approval of all promotional and non-promotional materials, including: Print and digital advertising, Sales training materials, Speaker programs and promotional events, Social media and digital campaigns, Disease awareness and unbranded materials, Medical Advisory Board and Focus Group materials, and Abstracts and publications.
• Ensure consistency of messaging with approved labeling, clinical data, scientific platform and regulatory commitments.
• Provide expert interpretation of labeling and clinical data to support compliant claims development.
• Partner with Commercial, Marketing, Medical Affairs, Legal, and Compliance teams to ensure promotional strategies are both effective and compliant.
• Participate in Promotional Review Committee (PRC) or Medical/Legal/Regulatory (MLR) review processes.
• Provide regulatory input into brand planning, launch readiness, and lifecycle management strategies.

Requirements

• Education and Experience: Bachelor’s degree in life sciences, chemistry, biochemistry, engineering, or related field. Advanced degree preferred. RAC or similar certification a plus. Approximately 15 years of Regulatory Affairs or related experience in the pharmaceutical/biotech industry with significant focus on advertising and promotion. Extensive experience with FDA OPDP regulations, guidance documents, and enforcement practices. Demonstrated leadership experience managing Ad/Promo review teams and processes. Experience supporting commercial product launches and lifecycle promotional activities. Knowledge of digital, social media, and emerging promotional channels and associated regulatory considerations.
• Skills and Abilities: Deep understanding of advertising and promotion regulations, including FDA OPDP, FD&C Act, 21 CFR 202.1, and global equivalents. Strong knowledge of labeling, clinical data interpretation, and substantiation of promotional claims. Proven ability to lead cross-functional teams and influence senior stakeholders. Strong decision-making skills in complex, high-visibility situations. Excellent written and verbal communication skills. Strong analytical and problem-solving capabilities. Ability to interpret complex regulatory requirements and translate them into actionable guidance. Experience managing promotional review processes, timelines, and workflows. Strong organizational and project management skills. Ability to operate effectively in a fast-paced, matrixed environment. Occasional travel required (~20%).

Benefits

• Liquidia offers a competitive compensation package as well as a comprehensive benefits package that includes Medical, Dental, Vision, STD, LTD, 401(k) Savings Retirement Plan, ESPP, Unlimited Paid Time Off and more!
• Liquidia is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
• Reasonable accommodation may be made to enable qualified individuals with disabilities to perform the essential functions of this position.