Director / Senior Director, Regulatory Affairs

Company: Soleno Therapeutics, Inc.
Location: Redwood City
Posted on: March 29, 2025

Job Description:

Director / Senior Director, Regulatory AffairsAbout Soleno Therapeutics IncSoleno 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 JobWe are seeking a highly motivated, enthusiastic, and experienced regulatory professional to join Soleno Therapeutics as the Director / Senior Director, Regulatory Affairs. This role will be responsible for providing strategic regulatory guidance to ensure compliance with all applicable regulations and guidelines for marketing authorization submissions outside the US. This role will collaborate closely with cross-functional teams to support product launches, lifecycle management, and other development and commercial activities. This role will be based out of our office in Redwood City, CA to foster a strong team and collaborative work dynamic.Responsibilities

• Contributes to the development of regulatory plans and strategies, identifies and proposes risk mitigation strategies, and influences project teams and sub teams across international site locations.
• Assist in developing and implementing strategies for the earliest possible approvals/clearance of regulatory submissions associated with assigned projects consistent with corporate goals and strategies.
• In close collaboration with local partners and/or CROs, proactively lead the preparation, submission, and maintenance of global regulatory dossiers while ensuring consistency of content and messaging across applications.
• 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.
• Prepares and/or manages submissions that may be technically complex and require extensive interaction with departments outside of regulatory affairs.
• Leads the drafting, review, and finalization of responses to queries from Regulatory Authorities.
• Maintains knowledge of regulatory requirements up to date and communicates changes in regulatory information within the regulatory department as well as to other departments.Qualifications
• A degree in a life science or closely related discipline with a higher degree preferred (e.g., MSc, MPH, PhD, PharmD).
• A minimum of 15 years direct pharmaceutical regulatory affairs, including 5 years of International Regulatory experience is required.
• Experience in a small company and hands-on marketing application experience from preparation through submission and approval in a non-oncology, rare disease indication is strongly preferred in regions including, but not limited to EU, APAC, and LATAM.
• Proven ability to manage multiple complex projects, with the flexibility and adaptability to re-prioritize workload.
• Proven proficiency in MS Word, Excel, Power Point, Visio, Adobe Acrobat. Must have experience with document formatting templates.
• Must be a hands-on team player who thrives in a fast-paced, team environment.
• 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 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.)
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Keywords: Soleno Therapeutics, Inc., Redwood City , Director / Senior Director, Regulatory Affairs, Executive , Redwood City, California