Director, Regulatory Affairs Advertising Promotion (Remote)

Role Summary

Director, Regulatory Affairs Advertising & Promotion (Remote) - Vertex is seeking an experienced Regulatory Affairs Advertising & Promotion Director to provide strategic regulatory direction for the review and approval of product, pipeline, and disease state communications for its pain assets in the US. The role ensures all promotional and nonpromotional communications meet regulatory requirements and support business objectives, collaborating cross-functionally to develop viable communications and implement processes that drive compliance and business success.

Responsibilities

• Serve as a regulatory expert on US statute, regulations, and relevant guidance governing product promotion and related communications, including pipeline and disease state communications for the pain franchise.
• Lead the Communications Review Committee (CRC), provide regulatory review support for the Medical Review Committee (MRC), and act as Global Regulatory Affairs Advertising and Promotion (GRAAP) representative on cross-functional teams.
• Chair the CRC for assigned products and therapeutic areas, leading discussions among Regulatory, Legal, Medical, Commercial, and other stakeholders to reach consensus.
• Assess regulatory context and provide interpretations of applicable guidance, regulations, and precedents, to proposed communications, as well as interpret and manage submission requirements to Health Authorities.
• Enhance collaboration across a matrixed organization and maintain constructive relationships with CRC stakeholders.
• Provide input for development products with promotional considerations, including contributions to target product profiles and proposed labeling, and ensure product labeling changes are accurately reflected in promotional materials in a timely manner.
• Lead cross-functional efforts to develop, update, and streamline procedures and guidelines related to CRC processes.
• Monitor and interpret advertising and promotion regulations, FTC and FDA compliance letters, and health authority guidances to support compliant marketing of Vertex products across a variety of communication medium.
• Lead training sessions for stakeholders as needed.

Qualifications

• High level of applied knowledge of Health Authority statutes, regulations, guidance, and industry standards related to advertising and promotional communications for prescription drugs, devices, and investigational treatments.
• In-depth understanding of clinical study design and statistical analyses necessary to support promotional claims and other communications.
• Familiarity with labeling regulations and global promotional review.
• Excellent interpersonal, communication (oral and written), project management, and presentation skills.
• Ability to lead, influence, resolve conflict, and drive consensus among diverse stakeholders.
• Solutions-driven mindset with strong reasoning and risk management skills.
• Experience in pharmaceutical industry regulatory advertising/promotion, including managing launch campaigns and interacting with Health Authorities.
• Bachelor‚Äôs degree in relevant/scientific discipline or a related field
• Typically requires 10 years of experience or the equivalent combination of education and experience

Skills

• Regulatory advertising/promotion expertise
• Leadership and cross-functional collaboration
• Strategic thinking and risk assessment
• Communication and presentation proficiency
• Ability to interpret guidance and manage submissions

Education

• Bachelor‚Äôs degree in relevant/scientific discipline or related field