Director / Senior Director, Regulatory Affairs, Advertising and Promotion

Role Summary

Soleno Therapeutics is seeking a Director / Senior Director, Labeling, Advertising, and Promotion to serve as the regulatory labeling and promotion expert. The role works with legal and applicable stakeholders to ensure promotional practices are compliant with regulatory requirements, guidelines, and company policies. In collaboration with the Regulatory Affairs team and other departments, you will review and support Soleno’s projects in rare diseases. The position is based in Redwood City, CA.

Responsibilities

• 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 to cross-functional partners, including regulatory input and guidance regarding marketing strategies, objectives, and plans
• Serve as primary Regulatory representative on MRC and PRC, and provide regulatory input on concept plans through draft materials
• Review, approve, and submit advertising / promotional materials, and serve as primary contact with FDA Office of Prescription Drug Promotion
• Propose creative and compliant regulatory strategies and solutions to unique or challenging promotional concepts that balance business objectives and regulatory risk

Qualifications

• At least 10 years of experience in regulatory advertising and promotion. Experience in a small company and in a fast-paced environment is strongly preferred.
• Proven proficiency with document formatting templates and familiarity with MS Word, Excel, PowerPoint, Visio, and Adobe Acrobat.
• Demonstrated in-depth knowledge of promotional regulations and guidance as well as standards and best practices.
• Strong, effective communication and organization skills, including negotiation and conflict resolution and an ability to collaborate cross-functionally.
• Proven ability to manage multiple complex projects, with the flexibility and adaptability to re-prioritize workload.
• Excellent verbal, written, negotiation and interpersonal skills are required. Must be articulate and able to communicate effectively both orally and in writing with employees at all levels of the global organization and external audiences.

Skills

• MS Word, Excel, PowerPoint, Visio, Adobe Acrobat; document formatting templates

Education

• Degree in a life science, chemistry, or chemical engineering or closely related discipline; graduate degree (e.g., PharmD) preferred.