Soleno Therapeutics, Inc.
Senior Associate, Regulatory Affairs
Soleno Therapeutics, Inc., Redwood City, California, United States, 94061
Soleno is a biopharmaceutical company focused on the development and commercialization of novel therapeutics for the treatment of rare diseases based in Redwood City, CA.
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 greatest asset, and we're expanding across functions during this pivotal time. We invite you to join us in making an impact—and making history.
We all share the most important goal of bringing solutions to the PWS community. Summary of Job (brief description)
The Senior Associate, Regulatory Affairs reports to a Senior Director, Regulatory Affairs and will support the senior Regulatory team members. We are seeking a highly motivated and enthusiastic individual to continue their growth in regulatory affairs by supporting the implementation of regulatory strategies for Soleno’s development programs from early phase through commercialization. The Senior Associate, Regulatory Affairs will be based at our headquarters in Redwood City, CA. Responsibilities
Prepare routine (e.g., new investigator information, etc.) submissions to health authorities in accordance with applicable regulations and guidelines. Participate in the preparation, review, and / or finalization of non-routine amendments to INDs and clinical trial applications. Collaborate with cross-functional teams to coordinate and facilitate delivery of submission documentation in accordance with pre-specified timelines. Perform regulatory research and assessments to inform global regulatory plans. Support preparation of responses to health authority requests. Support regulatory tracking, archival, and information management activities. Participate in the review of critical documents such as protocols, patient information sheets / informed consent forms, Investigator’s Brochures, Clinical Study Reports, DSURs, etc. to support their completeness and conformance with relevant regulations and guidance (e.g. ICH, FDA, EMA, etc.) prior to submission. Additional activities as requested. Work is performed under direction of a Senior Regulatory Affairs professional. Qualifications
A degree in a life science or closely related discipline with a graduate degree preferred and a minimum of 2 years of experience in pharmaceutical / biotechnology regulatory affairs or similar role. Experience in a small company is preferred. Proven proficiency in MS Word, Excel, Power Point, Visio, Adobe Acrobat. Must have experience with document formatting templates. Working knowledge of US regulations and relevant guidelines (e.g., FDA, ICH, etc.) and knowledge of the drug development process. Experience with preparation of CTA and IND submissions in eCTD format in at least one country. Proficiency in reviewing electronic submissions prior to submission by third-party publisher. Must be able to work independently and as a team player. Must be able to manage multiple concurrent projects, adapt to changing priorities across project teams, and complete submissions in alignment with project timelines. Must be accustomed to working in a fast-paced 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 global organization and external audiences. Must have a high level of attention to detail. Salary Range
$95,000 - $130,000 (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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We all share the most important goal of bringing solutions to the PWS community. Summary of Job (brief description)
The Senior Associate, Regulatory Affairs reports to a Senior Director, Regulatory Affairs and will support the senior Regulatory team members. We are seeking a highly motivated and enthusiastic individual to continue their growth in regulatory affairs by supporting the implementation of regulatory strategies for Soleno’s development programs from early phase through commercialization. The Senior Associate, Regulatory Affairs will be based at our headquarters in Redwood City, CA. Responsibilities
Prepare routine (e.g., new investigator information, etc.) submissions to health authorities in accordance with applicable regulations and guidelines. Participate in the preparation, review, and / or finalization of non-routine amendments to INDs and clinical trial applications. Collaborate with cross-functional teams to coordinate and facilitate delivery of submission documentation in accordance with pre-specified timelines. Perform regulatory research and assessments to inform global regulatory plans. Support preparation of responses to health authority requests. Support regulatory tracking, archival, and information management activities. Participate in the review of critical documents such as protocols, patient information sheets / informed consent forms, Investigator’s Brochures, Clinical Study Reports, DSURs, etc. to support their completeness and conformance with relevant regulations and guidance (e.g. ICH, FDA, EMA, etc.) prior to submission. Additional activities as requested. Work is performed under direction of a Senior Regulatory Affairs professional. Qualifications
A degree in a life science or closely related discipline with a graduate degree preferred and a minimum of 2 years of experience in pharmaceutical / biotechnology regulatory affairs or similar role. Experience in a small company is preferred. Proven proficiency in MS Word, Excel, Power Point, Visio, Adobe Acrobat. Must have experience with document formatting templates. Working knowledge of US regulations and relevant guidelines (e.g., FDA, ICH, etc.) and knowledge of the drug development process. Experience with preparation of CTA and IND submissions in eCTD format in at least one country. Proficiency in reviewing electronic submissions prior to submission by third-party publisher. Must be able to work independently and as a team player. Must be able to manage multiple concurrent projects, adapt to changing priorities across project teams, and complete submissions in alignment with project timelines. Must be accustomed to working in a fast-paced 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 global organization and external audiences. Must have a high level of attention to detail. Salary Range
$95,000 - $130,000 (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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