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Regulatory Affairs Manager

Date: 19 Oct 2015
Location: United States, Boston
Salary: Competitive

A growing pharmaceutical company in Boston is seeking a Regulatory Affairs Manager for a 6 month contract. This position will interact with different project teams in the planning and preparation of regulatory submissions. 

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
Qualifications:
  • Bachelor's degree in scientific field
  • 5+ years regulatory experience
  • Strong familiarity with FDA and EMA clinical/CMC guidelines
  • Excellent communication skills, particularly written

If you're looking to further your career with an innovative, up-and-coming organization, now is the time! Please submit your updated CV to apply.a33ho1fqkct@epmscientific.aptrack.co.uk.
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