Director​/Senior Director, Regulatory Affairs, Advertising and Promotion

Role Summary

The Director / Senior Director, Labeling, Advertising, and Promotion will serve as the regulatory labeling and promotion expert and, with legal and applicable stakeholders, ensure promotional practices are consistent with regulatory requirements, guidelines, policies, and procedures. Based in Redwood City, CA, this role collaborates across departments to provide reviews and support for Soleno’s projects in rare diseases.

• Lead regulatory strategy and oversight for all promotional activities and communications
• Provide strategic advice and recommendations in the development of promotional concepts and product campaigns, including regulatory input to marketing strategies, objectives, and plans
• Serve as primary Regulatory representative on MRC and PRC, providing input on concept plans through draft materials
• Review, approve, and submit advertising/promotional materials; act as primary contact with FDA Office of Prescription Drug Promotion
• Propose creative and compliant regulatory strategies for unique promotional concepts balancing business objectives and regulatory risk

• Degree in life science, chemistry, chemical engineering, or related discipline; graduate degree (e.g., Pharm
  
  D) preferred; at least 10 years of experience in regulatory advertising and promotion; experience in a small company and fast-paced environment strongly preferred
• Proficiency in MS Word, Excel, PowerPoint, Visio, Adobe Acrobat; experience with document formatting templates
• In-depth knowledge of promotional regulations, guidance, standards, and best practices
• Strong communication and organizational skills, including negotiation and conflict resolution; ability to collaborate cross-functionally
• Proven ability to manage multiple complex projects with flexibility to reprioritize
• Excellent verbal and written communication; ability to communicate effectively with employees at all levels and external audiences