Senior Associate, Regulatory Affairs

Soleno

Redwood City, CA, United States
Base: $95,000 - $130,000; bonus/equity: not specif...
On-site
Preparation of ind and cta submissions
Knowledge of fda and ich regulations
Proficiency in ms word, excel, powerpoint
Soleno is a biopharmaceutical company focused on developing novel therapeutics for rare diseases and is driven by the needs of the PWS community

Job Summary

  • Soleno is a biopharmaceutical company focused on developing novel therapeutics for rare diseases and is driven by the needs of the PWS community.
  • The Senior Associate, Regulatory Affairs will support senior regulatory team members in implementing regulatory strategies from early phase through commercialization.
  • The role involves preparing submissions, performing regulatory research, and collaborating with cross-functional teams to meet project timelines.

Matching Summary

Soleno is a biopharmaceutical company focused on developing novel therapeutics for rare diseases and is driven by the needs of the PWS community.

Salary

Base: $95,000 - $130,000; Bonus/Equity: Not specified; Benefits: Not specified

Skills & Requirements

Must-have

  • preparation of IND and CTA submissions
  • knowledge of FDA and ICH regulations
  • proficiency in MS Word, Excel, PowerPoint
  • experience with document formatting templates
  • ability to manage multiple concurrent projects
  • review of regulatory documents for compliance

Nice-to-have

  • experience in small company environment
  • collaboration with cross-functional teams
  • strong verbal and written communication skills
  • adaptability in fast-paced environment
  • attention to detail
  • team player mindset

Key Requirements

  • minimum 2 years pharmaceutical regulatory affairs experience
  • degree in life science or related discipline
  • experience with eCTD format submissions
  • working knowledge of US regulations and drug development process

Work Rights

Not specified

Tailored Resume

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