Director, Regulatory CMC, Severe Genetic Disease in Cambridge, MA



$200K - $250K*


Life Sciences


5 - 7 years

Job Description

bluebird bio is looking for a Director in Regulatory CMC for biologics who will be responsible for the strategic development and submission of regulatory filings for one of the lead gene therapy projects at bluebird bio both in the US and internationally. In this position you will be responsible for driving the development of innovative CMC regulatory strategies and the preparation and submission of high‑quality CMC sections of INDs, CTAs, and original marketing applications (BLAs/MAAs), in close collaboration with our in-house Pharmaceutical Sciences, Quality and Manufacturing teams, contract manufacturing organizations, external experts and global health authorities.

About the role:

  • Responsible for CMC regulatory activities for late stage gene therapy project
  • Manage and implement planning, preparation and submission of high-quality CMC‑related applications in the US, EU and other regions
  • Ensure that CMC-related applications, incl
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Valid through: 2020-5-19

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