Executive Director, Regulatory Affairs, Advertising and Promotion

Liquidia•,

2h•Hybrid

About The Position

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.

Requirements

Bachelor’s degree in life sciences, chemistry, biochemistry, engineering, or related field.
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.
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.

Nice To Haves

Advanced degree preferred.
RAC or similar certification a plus.

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, 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.
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.
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.
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.