Executive Director, Regulatory Affairs, Advertising and Promotion

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🔥 2 hours ago

🌲 North Carolina – Remote

🌲 North Carolina – Remote

⏰ Full Time

🔴 Lead

🚔 Compliance

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Liquidia Corporation

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2004

🧬 Biotechnology

💊 Pharmaceuticals

💰 $75M Post IPO equity on 2024-02

Biotechnology • Pharmaceuticals

Liquidia is a biopharmaceutical company focused on developing inhaled therapies for rare cardiopulmonary diseases, particularly pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). The company leverages its proprietary PRINT® particle engineering technology to create proprietary formulations and delivery methods aimed at improving efficacy, tolerability, and convenience of inhaled medicines; its pipeline includes inhaled treprostinil (commercial product) and clinical-stage candidates such as L606. Liquidia emphasizes patient support, clinical development, and advancing therapies for improved respiratory outcomes.

📋 Description

• *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.

🎯 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, 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%).

🏖️ 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!