Soleno Therapeutics, Inc. · 1 week ago
Director / Senior Director, Regulatory Affairs, Advertising and Promotion
Redwood City, CA
Full-time
Onsite
Director/Executive
$220K/yr - $280K/yr
10+ years expSoleno Therapeutics, Inc. is a biopharmaceutical company focused on developing novel therapeutics for rare diseases. They are seeking a Director / Senior Director of Regulatory Affairs, Advertising, and Promotion to lead regulatory strategy for promotional activities and ensure compliance with regulatory requirements and company policies.
BiotechnologyMedicalPharmaceutical
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
Qualification
Required
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
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
Preferred
Experience in a small company and in a fast-paced environment is strongly preferred
Company
Soleno Therapeutics, Inc.
At Soleno Therapeutics, we believe in the power of science, advocacy, and community.
51-200 employees
Funding
Current Stage
Public CompanyTotal Funding
$569.2MKey Investors
Oxford Finance LLCAbingworth
2025-07-10Post Ipo Equity· $200M
2024-12-17Post Ipo Debt· $50M
2024-05-02Post Ipo Equity· $158.7M
Leadership Team
Jim Mackaness
Chief Financial Officer
Recent News
Company data provided by crunchbase