Responsibilities

• The Executive Director, Regulatory Affairs, Advertising and Promotion is responsible for providing strategic and operational aspects of promotional and non-promotional communications across the product lifecycle.
• This role ensures all external and internal communications – including marketing materials, digital content, scientific exchange, and labeling-derived claims – are compliant with global regulatory requirements (especially FDA), company policies, and applicable industry standards.
• The Executive Director partners closely with Commercial, Medical Affairs, Legal, Compliance, and clinical teams to enable compliant, effective communication of product benefits and risks while supporting business objectives.
• 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; Abstracts and publications.
• Ensure consistency of messaging with approved labeling, clinical data, scientific platform and regulatory commitments.

Requirements

• 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, Skills, and Abilities - Deep understanding of advertising and promotion regulations, including FDA OPDP, FD&C Act, 21 CFR 202.1, and global equivalents.
• Knowledge, Skills, and Abilities - Strong knowledge of labeling, clinical data interpretation, and substantiation of promotional claims.
• Knowledge, Skills, and Abilities - Familiarity with digital, social media, and emerging promotional channels and associated regulatory considerations.
• Knowledge, Skills, and Abilities - Proven ability to lead cross-functional teams and influence senior stakeholders.
• Knowledge, Skills, and Abilities - Strong decision-making skills in complex, high-visibility situations.

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!