What are the responsibilities and job description for the Director / Senior Director, Regulatory Affairs position at Soleno Therapeutics Inc?
Director / Senior Director, Regulatory Affairs
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 (brief description)
We 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 withing the regulatory department as well as to other departments.
Qualifications
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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Salary : $230,000 - $280,000
