Senior Manager, Regulatory Affairs

Apogee Therapeutics IncA

Remote, US
Base: $155,000-$175,000; bonus/equity: performance...
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5 years regulatory experience in drug development
Experience interacting with fda and ema
Strong project management skills
** Apogee Therapeutics, Inc. is seeking a Senior Manager of Regulatory Affairs to join their remote team. The role involves overseeing regulatory strategies for the company's innovative biologics, ensuring compliance with FDA and international regulations, and contributing to the fast-paced culture of the organization. **

Job Summary

  • This newly created role offers an opportunity to work in a fast-paced environment where you help shape the culture and company while wearing multiple hats.
  • You will lead the preparation and completion of documentation to support submissions to the FDA and ex-US regulatory agencies including INDs, NDAs, and BLAs.
  • The position offers market competitive compensation including base salary, performance bonus, equity grants, health benefits, and three weeks of PTO.

Matching Summary

Match Score: 75

** Apogee Therapeutics, Inc. is seeking a Senior Manager of Regulatory Affairs to join their remote team. The role involves overseeing regulatory strategies for the company's innovative biologics, ensuring compliance with FDA and international regulations, and contributing to the fast-paced culture of the organization. **

Salary

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

Skills & Requirements

Must-have

  • 5 years regulatory experience in drug development
  • Experience interacting with FDA and EMA
  • Strong project management skills
  • Veeva RIM platform experience
  • eCTD submission expertise

Nice-to-have

  • RAC credential preferred
  • Microsoft Office SharePoint/Teams proficiency
  • Ability to present to diverse stakeholders
  • C.O.R.E. values alignment: Caring Original Resilient Egoless

Key Requirements

  • BS/MS/PhD in regulatory affairs or related scientific discipline
  • Minimum 5 years of regulatory experience in biopharmaceutical industry
  • Regulatory Affairs Certification (RAC) preferred
  • Up to 10% travel including mandatory in-person attendance

Work Rights

Not specified

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