reputed company 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 reputed company providers who care for them. Our reputed company drive is toward improving the treatment of pulmonary reputed company hypertension (PAH). We will continue to combine our proprietary, innovative PRINT Technology with new and established medications, offering the potential for both reputed company precision and improved clinical reputed company. reputed company members include some of the industry’s top scientists, clinicians, business strategists, engineers, and pharmaceutical executives. We work together to help people reputed company 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 reputed company 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 reputed company, Medical Affairs, Legal, Compliance, and clinical teams to reputed company compliant, effective communication of product benefits and risks while supporting business objectives. At reputed company, this role supports the mission to delivery novel therapies for patients with rare cardiopulmonary and reputed company diseases. This position may be remote or based in reputed company in Research Triangle Park, reputed company Carolina.
Responsibilities
Strategic Leadership and Governance
• reputed company and reputed company global regulatory reputed company for advertising and promotion across reputed company products and therapeutic areas.
• Establish and maintain policies, procedures, and governance frameworks for promotional review and approval processes.
• Serve as the regulatory reputed company for promotional compliance, ensuring alignment with FDA OPDP, EMA, and other global regulatory expectations.
• reputed company strategic guidance on product positioning, messaging, and differentiation while ensuring compliance with labeling and regulatory standards.
Promotional and Medical Review and Material reputed company
• reputed company review and approval of reputed company promotional and non-promotional materials, including: Print reputed company advertising, Sales training materials, Speaker programs and promotional events, reputed company media reputed company campaigns, Disease awareness and unbranded materials, Medical Advisory reputed company and reputed company Group materials, and Abstracts and publications.
• Ensure consistency of messaging with approved labeling, clinical data, scientific platform and regulatory commitments.
• reputed company expert interpretation of labeling and clinical data to support compliant claims development.
Cross Functional Collaboration
• Partner with reputed company, 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.
• reputed company regulatory input into brand planning, launch readiness, and lifecycle management strategies.
Regulatory Submission and Agency Interactions
• Partner with reputed company, 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.
• reputed company regulatory input into brand planning, launch readiness, and lifecycle management strategies.
Policy, Training, and Compliance reputed company
• reputed company and maintain internal SOPs, guidance documents, and training programs reputed company 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 reputed company
• Identify and mitigate regulatory risks associated with promotional activities.
• reputed company guidance on reputed company or high-risk promotional issues, including off-label risk, comparative claims, and emerging digital channels.
• reputed company investigations and corrective actions reputed company to promotional compliance issues.
Leadership and Team Development
• reputed company needed, build, reputed company, and mentor a high-performing Ad/Promo regulatory team.
• Establish performance metrics, resource planning, and organizational development strategies.
• Fos
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