Manager, Regulatory Affairs

Generate:Biomedicines

Somerville, MA, United States
Base: $127,000 - $165,000 usd py; bonus/equity: el...
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3-5+ years regulatory affairs experience
Bachelor's degree in scientific discipline
Experience leading ind and cta submissions
** Generate:Biomedicines is seeking a Regulatory Affairs Manager to oversee global regulatory activities for biologic therapeutics. The ideal candidate will have extensive regulatory experience, strong technical writing skills, and the ability to thrive in a fast-paced environment. **

Job Summary

  • The role involves independently managing key submission components and contributing to regulatory strategy for biologic therapeutics.
  • Candidates will act as primary authors for regulatory sections and coordinate responses to health authority queries.
  • The position offers the opportunity to shape a new era in biomedicine by integrating machine learning with large-scale experimentation.

Matching Summary

Match Score: 75

** Generate:Biomedicines is seeking a Regulatory Affairs Manager to oversee global regulatory activities for biologic therapeutics. The ideal candidate will have extensive regulatory experience, strong technical writing skills, and the ability to thrive in a fast-paced environment. **

Salary

Base: $127,000 - $165,000 USD per year; Bonus/Equity: Eligible for annual bonus and equity compensation; Benefits: Competitive benefits package included

Skills & Requirements

Must-have

  • 3-5+ years regulatory affairs experience
  • Bachelor's degree in scientific discipline
  • Experience leading IND and CTA submissions
  • Strong technical writing skills
  • Knowledge of US and EU regulatory requirements

Nice-to-have

  • Advanced degree preferred
  • Experience with biologics development
  • Familiarity with Veeva Vault RIM system
  • Mentoring junior staff capabilities
  • Collaborative and solutions-focused mindset

Key Requirements

  • Bachelor's degree required; advanced degree preferred
  • 3-5+ years in biotech/pharma regulatory affairs
  • Demonstrated experience drafting key regulatory documents
  • Familiarity with eCTD publishing and electronic submissions

Work Rights

Not specified

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