Soleno Therapeutics Inc
Associate Director / Director, Regulatory Affairs
Soleno Therapeutics Inc, Redwood City, California, United States, 94061
Associate Director / Director, Regulatory Affairs
About 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. Our team is made up of exceptional colleagues whose collective efforts are woven together to deliver meaningful outcomes 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.Our employees are our most important asset, and we are looking to expand across many functions during this important and pivotal time.Summary of JobWe are seeking a highly motivated and enthusiastic individual to join Soleno Therapeutics’ growing regulatory affairs group. Together with the Regulatory Affairs team and in close collaboration with other departments, the Associate Director / Director, Regulatory Affairs will take a hands-on approach to developing and implementing regulatory strategies for our development programs in rare diseases. The Associate Director / Director, Regulatory Affairs will be based at our office in Redwood City, CA in a primarily hybrid work environment.ResponsibilitiesResponsible for strategic and operational regulatory input and support for collaboration with project team members, including regulatory team members.Contributes to the development of regulatory plans and strategies, identifies and proposes risk mitigation strategies, and influences project teams across international site locations.Assist in developing and implementing strategies for the earliest possible approvals/clearance of regulatory submissions associated with assigned projects.Prepares and/or manages submissions that may be technically complex and require extensive interaction with departments outside of regulatory affairs.Provide regulatory advice and information to cross-functional teams 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 and communicates changes in regulatory information to other departments.QualificationsA degree in a life science, chemistry, or chemical engineering or closely related discipline with a graduate degree preferred and at least 10 years of experience in pharmaceutical regulatory affairs, including CMC regulatory affairs.Strong track record of contributing to regulatory submissions.Experience in a small company and in a fast-paced environment is preferred.Proven proficiency in MS Word, Excel, PowerPoint, Visio, Adobe Acrobat.Experience with document formatting templates.Regulatory experience in the development of modified-release solid oral dosage forms is highly preferred, and experience in the development of small molecules is required.Established track record of drafting, reviewing, and finalizing successful regulatory submissions and Regulatory Authority interactions.Recent NDA experience from late phase 3 study, pre-NDA meeting, NDA preparation through product approval is a plus.Proven ability to manage multiple complex projects, with flexibility and adaptability to re-prioritize workload.Excellent verbal, written, negotiation, and interpersonal skills are required.Salary Range:
$170,000-$250,000(Actual salary at the time of hire may vary and may be above or below the range based on various factors, including the candidate’s relevant qualifications, skills, and experience, as well as the location where this position may be filled.)
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About 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. Our team is made up of exceptional colleagues whose collective efforts are woven together to deliver meaningful outcomes 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.Our employees are our most important asset, and we are looking to expand across many functions during this important and pivotal time.Summary of JobWe are seeking a highly motivated and enthusiastic individual to join Soleno Therapeutics’ growing regulatory affairs group. Together with the Regulatory Affairs team and in close collaboration with other departments, the Associate Director / Director, Regulatory Affairs will take a hands-on approach to developing and implementing regulatory strategies for our development programs in rare diseases. The Associate Director / Director, Regulatory Affairs will be based at our office in Redwood City, CA in a primarily hybrid work environment.ResponsibilitiesResponsible for strategic and operational regulatory input and support for collaboration with project team members, including regulatory team members.Contributes to the development of regulatory plans and strategies, identifies and proposes risk mitigation strategies, and influences project teams across international site locations.Assist in developing and implementing strategies for the earliest possible approvals/clearance of regulatory submissions associated with assigned projects.Prepares and/or manages submissions that may be technically complex and require extensive interaction with departments outside of regulatory affairs.Provide regulatory advice and information to cross-functional teams 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 and communicates changes in regulatory information to other departments.QualificationsA degree in a life science, chemistry, or chemical engineering or closely related discipline with a graduate degree preferred and at least 10 years of experience in pharmaceutical regulatory affairs, including CMC regulatory affairs.Strong track record of contributing to regulatory submissions.Experience in a small company and in a fast-paced environment is preferred.Proven proficiency in MS Word, Excel, PowerPoint, Visio, Adobe Acrobat.Experience with document formatting templates.Regulatory experience in the development of modified-release solid oral dosage forms is highly preferred, and experience in the development of small molecules is required.Established track record of drafting, reviewing, and finalizing successful regulatory submissions and Regulatory Authority interactions.Recent NDA experience from late phase 3 study, pre-NDA meeting, NDA preparation through product approval is a plus.Proven ability to manage multiple complex projects, with flexibility and adaptability to re-prioritize workload.Excellent verbal, written, negotiation, and interpersonal skills are required.Salary Range:
$170,000-$250,000(Actual salary at the time of hire may vary and may be above or below the range based on various factors, including the candidate’s relevant qualifications, skills, and experience, as well as the location where this position may be filled.)
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