Director / Senior Director, Regulatory Affairs, Advertising and Promotion
About The Position
Soleno Therapeutics, Inc., based in Redwood City, California, is a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases. We are seeking a highly motivated and enthusiastic individual to join Soleno Therapeutics’ growing regulatory affairs group. The Director / Senior Director, Labeling, Advertising, and Promotion will serve as the regulatory labeling and promotion expert and together with legal and applicable stakeholders, ensure that promotional practices are consistent with applicable regulatory requirements, guidelines, company policies, and procedures. Together with the Regulatory Affairs team and in close collaboration with other departments at Soleno Therapeutics, the Director / Senior Director, Advertising, and Promotion will take a hands-on approach to providing the necessary reviews and support for Soleno’s projects in rare diseases. The Director / Senior Director, Advertising, and Promotion will be based at our office in Redwood City, CA to foster a strong team and collaborative dynamic.
Requirements
- A degree in a life science, chemistry, or chemical engineering or closely related discipline with a graduate degree (e.g., PharmD) preferred and 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 in MS Word, Excel, Power Point, Visio, Adobe Acrobat. Must have experience with document formatting templates.
- 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.
Responsibilities
- Lead regulatory strategy and oversight for all promotional activities and communications
- Provide strategic advice and recommendations in the development of promotional concepts, product campaigns to cross-functional partners, including regulatory input and guidance to relevant stakeholders 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, approval, and submission of 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
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What This Job Offers
Job Type
Full-time
Career Level
Director
Education Level
Ph.D. or professional degree
Number of Employees
101-250 employees
