Executive Director, Regulatory Affairs, Advertising and Promotion

Liquidia is deeply passionate and committed to the discovery, engineering, and development required to bring novel therapies to patients who need them most, and to the healthcare providers who care for them. Our current drive is toward improving the treatment of pulmonary arterial hypertension (PAH). We will continue to combine our proprietary, innovative PRINT Technology with new and established medications, offering the potential for both better precision and improved clinical outcomes. Our team members include some of the industry’s top scientists, clinicians, business strategists, engineers, and pharmaceutical executives. We work together to help people lead longer, healthier, and happier lives. Job Summary: 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. At Liquidia, this role supports the mission to delivery novel therapies for patients with rare cardiopulmonary and related diseases. This position may be remote or based in Liquidia in Research Triangle Park, North Carolina. 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, 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.
• Familiarity with digital, social media, and emerging promotional channels and associated regulatory considerations.
• Proven ability to lead cross-functional teams and influence senior stakeholders.
• Strong decision-making skills in complex, high-visibility situations.
• Ability to balance compliance requirements with business objectives.
• 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%).

Strategic Leadership and Governance

• 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.

Promotional and Medical Review and Material Oversight

• 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.
• Provide expert interpretation of labeling and clinical data to support compliant claims development.

Cross Functional Collaboration

• 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.

Regulatory Submission and Agency Interactions

• 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.

Policy, Training, and Compliance Oversight

• Develop and maintain internal SOPs, guidance documents, and training programs related to advertising and promotion.
• Train cross-functional teams on regulatory requirements, promotional compliance, and emerging regulatory trends.
• Monitor and interpret evolving regulatory guidance and enforcement trends; implement changes to internal processes accordingly.

Risk Management and Issue Resolution

• Identify and mitigate regulatory risks associated with promotional activities.
• Provide guidance on complex or high-risk promotional issues, including off-label risk, comparative claims, and emerging digital channels.
• Lead investigations and corrective actions related to promotional compliance issues.

Leadership and Team Development

• When needed, build, lead, and mentor a high-performing Ad/Promo regulatory team.
• Establish performance metrics, resource planning, and organizational development strategies.
• Foster a culture of support within regulatory of compliance, accountability, and cross-functional collaboration.

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. Recruiting Agencies, Please Note : Liquidia will not accept unsolicited assistance from recruiting/search agencies for this employment opportunity. Please, no phone calls or emails. All resumes submitted by recruiting or search agencies to any employee at Liquidia via email, the Internet or in any form and/or method without a valid written search/recruitment agreement in place for this position will be deemed the sole property of Liquidia. No fee will be paid in the event the candidate is hired by Liquidia as a result of the referral or through other means. Apply To This Job