Director / Senior Director, Regulatory Affairs Labeling, Advertising, and Promot

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

About Soleno Therapeutics Inc

Soleno Therapeutics, Inc., based in Redwood City, California, is a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, including Prader-Willi syndrome (PWS).

At Soleno, we are driven by the unique and multi-faceted needs of the PWS community. Like these individuals, resilience is part of who we are – it is in our chromosomes – and our team is made up of exceptional colleagues whose collective efforts are woven together to deliver meaningful outcomes, both professionally and for those living with PWS.

We value collaboration, integrity, and respect. These characteristics have allowed us to forge strong, authentic bonds with the caregivers, patients, health care professionals (HCPs) and community members we serve. We are proud to work alongside them every step of the way.

Our employees are our most important asset, and we are looking to expand across many functions during this important and pivotal time. We encourage you to join us in making history. We all share the most important goal of bringing solutions to the PWS community. They are waiting.

Summary of Job

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, Labeling, 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, Labeling, Advertising, and Promotion will be based at our office in Redwood City, CA to foster a strong team and collaborative dynamic.

Responsibilities

• Accountable for oversight of the labeling process for all programs from development through commercialization globally.
• Provide regulatory input and guidance to relevant stakeholders regarding marketing strategies, promotion objectives, and plans.
• Provide regulatory input on concept plans through draft materials. Serve as primary Regulatory reviewer and approver of all labeling and promotional materials.
• Review and approve all promotional materials.
• Serve as regulatory representative on MRC and PRC.
• Serve as primary regulatory liaison to FDA’s 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.
• Develop and maintain target product profile, company core datasheet, patient labeling, USPI, and summary of product characteristics or equivalents internationally.
• Provide regulatory advice and information to cross-functional teams and to other functional areas (i.e., CMC, nonclinical, and clinical) for product development and planning to support the timely achievement of company and department goals.
• Leads the drafting, review, and finalization of responses to queries from Regulatory Authorities.
• Maintains knowledge of regulatory requirements up to current date and communicates changes in regulatory information to other departments.

Qualifications

• A degree in 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 labeling and advertising/promotion activities. 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.

Salary Range: $230,000 - $280,000

(Actual salary at the time of hire may vary and may be above or below the range based on various factors, including, but not limited to, the candidate’s relevant qualifications, skills, and experience, as well as the location where this position may be filled.)