Senior Manager, Regulatory Affairs

Apogee Therapeutics

Remote, US
Base: $155,000-$175,000; bonus/equity: performance...
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5+ years drug development experience
Fda and ema interaction experience
Veeva rim platform proficiency
** Apogee Therapeutics is hiring a Senior Manager of Regulatory Affairs to oversee regulatory strategies and submissions for their innovative biologics targeting inflammatory and autoimmune conditions. The position, which is remote, requires strong regulatory experience in drug development, with a focus on collaboration and communication across teams. **

Job Summary

  • This newly created role offers the opportunity to oversee regulatory strategies for Apogee's novel biologics in a fast-paced clinical-stage environment.
  • The successful candidate will serve as the primary interface with regulatory publishing to ensure timely and compliant electronic submissions to the FDA and ex-US agencies.
  • Apogee Therapeutics offers a competitive compensation package including base salary, performance bonus, equity grants, and three weeks of PTO.

Matching Summary

Match Score: 75

** Apogee Therapeutics is hiring a Senior Manager of Regulatory Affairs to oversee regulatory strategies and submissions for their innovative biologics targeting inflammatory and autoimmune conditions. The position, which is remote, requires strong regulatory experience in drug development, with a focus on collaboration and communication across teams. **

Salary

Base: $155,000-$175,000; Bonus/Equity: Performance bonus and equity grant opportunities; Benefits: Health, welfare, retirement benefits, three weeks PTO

Skills & Requirements

Must-have

  • 5+ years drug development experience
  • FDA and EMA interaction experience
  • Veeva RIM platform proficiency
  • eCTD submission expertise
  • IND NDA BLA submission coordination

Nice-to-have

  • RAC certification preferred
  • Microsoft Office SharePoint/Teams skills
  • C.O.R.E. values alignment
  • Cross-functional collaboration skills
  • Fast-paced environment adaptability

Key Requirements

  • BS/MS/PhD in regulatory affairs or related science
  • Minimum 5 years regulatory experience in biopharma
  • Experience interacting with FDA and EMA health authorities

Work Rights

Not specified

Tailored Resume

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