Posted to MedZilla on 1/20/2020

Phaidon International

US-MA, Regulatory Affairs Manager 452431259256-MZ


A growing pharmaceutical company in Boston is seeking a Regulatory Affairs Manager on a contract basis. 

The company is based in South Boston and focuses on the treatment of cancers including multiple myeloma as well as neurodegenerative, inflammatory, metabolic, genetic and infectious parasitic diseases.

Key responsibilities:

  • Manage preparation/review of CMC and clinical submissions
  • Review technical documentation to ensure regulatory compliance
  • Assist with research/implementation of effective regulatory strategies
  • Ensure compliance with existing regulatory applications
  • Bachelor's degree in scientific field
  • 5+ years regulatory experience
  • Experience in oncology environment
  • Strong familiarity with FDA and EMA clinical/CMC guidelines
  • Excellent communication skills, particularly written

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