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Jobs / Massachusetts Jobs / Cambridge Jobs / Biochemists Jobs / Regulatory Affairs CMC Director - Pioneer Cell Therapy Regulatory Strategy
Regulatory Affairs CMC Director - Pioneer Cell Therapy Regulatory Strategy
Employer
BlueRock Therapeutics
Salary
$160k-$180k (estimated pay)
Location
Cambridge, MA
Employment Type
Full-time
Сategory
Biochemists
Description
Lead regulatory CMC efforts in cutting-edge cell and gene therapy development at BlueRock Therapeutics, a leader in engineered cellular medicines.
Qualifications
  • 10+ years in Regulatory Affairs
  • Expertise in biologics
  • Experience with Health Authority submissions
Responsibilities
  • Lead regulatory CMC matrix teams
  • Provide strategic guidance on regulatory requirements
  • Interface with Health Authorities for submissions
Education
Bachelor's degree in relevant field required
Working Hours
Standard business hours, occasional travel up to 25%
Benefits
  • Health insurance
  • 401(k) matching
  • Paid time off
Keywords
Cell therapy regulatory affairs gene therapy CMC biologics

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