Senior Manager, Regulatory Affairs Cmc

Spyre Therapeutics

Remote, United States
Base: $150,000 to $176,000; bonus/equity: performa...
Remote
Cmc regulatory affairs experience
Authoring module 2 and 3 sections
Ind and impd submission leadership
This role involves leading the Regulatory CMC strategy and execution from early development through clinical milestones for multiple programs

Job Summary

  • This role involves leading the Regulatory CMC strategy and execution from early development through clinical milestones for multiple programs.
  • The successful candidate will personally author critical sections of Module 2 and 3 submissions including drug substance, drug product, and comparability data.
  • The company offers a competitive compensation package with equity grants, unlimited PTO, and a remote working environment with frequent in-person meetings.

Matching Summary

This role involves leading the Regulatory CMC strategy and execution from early development through clinical milestones for multiple programs.

Salary

Base: $150,000 to $176,000; Bonus/Equity: Performance bonus and equity grant opportunities; Benefits: Health, welfare, retirement benefits, unlimited PTO

Skills & Requirements

Must-have

  • CMC regulatory affairs experience
  • Authoring Module 2 and 3 sections
  • IND and IMPD submission leadership
  • Health authority response preparation
  • Global CMC regulatory requirements knowledge

Nice-to-have

  • EU CTR and ROW experience
  • Veeva RIM proficiency
  • Fast-paced biotech environment adaptability
  • Cross-functional team collaboration skills

Key Requirements

  • Bachelor's degree required
  • Minimum 5 years CMC regulatory experience
  • Experience as primary CMC lead for clinical stage programs
  • Hands-on authoring experience for IND and IMPD submissions

Work Rights

Not specified

Tailored Resume

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