Senior Associate, Regulatory Affairs
SolenoRedwood City, California, United States
Posted January 7, 2026
95000 - 130000 USD year
Full Time
About the Company
Soleno Therapeutics Inc is a biopharmaceutical company focused on the development and commercialization of novel therapeutics for the treatment of rare diseases.
Job Description
Soleno Therapeutics Inc is a biopharmaceutical company seeking a Senior Associate, Regulatory Affairs to support the implementation of regulatory strategies for its development programs. The role involves preparing submissions to health authorities, collaborating with cross-functional teams, and performing regulatory research and assessments.
Requirements
- A degree in a life science or closely related discipline with a graduate degree preferred
- A minimum of 2 years of experience in pharmaceutical / biotechnology regulatory affairs or similar role
- Proven proficiency in MS Word, Excel, Power Point, Visio, Adobe Acrobat
- Working knowledge of US regulations and relevant guidelines (e.g., FDA, ICH, etc.)
- Experience with preparation of CTA and IND submissions in eCTD format in at least one country
- Excellent verbal, written, negotiation and interpersonal skills
