Regulatory CMC, Director in Cambridge, MA

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compensation:

$200K - $250K*

specialty:

Life Sciences

experience:

11 - 15 years

Job Description

About the Role:

  • Lead CMC early oncology regulatory activities and timelines
  • Lead planning, preparation and submission of high-quality CMC‑related applications in the US and EU
  • Ensure that CMC-related applications and/or sections, including INDs/CTAs, investigator brochures and pediatric investigation plans, and MAAs or BLAs are complete, well written, and meet all relevant requirements
  • Participate in negotiations with regulatory agencies to resolve CMC issues and shepherd proactive interactions with regulators globally; prepare and submit responses to CMC questions; participate as needed in interactions with regulatory agencies during GMP and pre-approval inspections
  • Drive adherence to CMC regulatory guidelines relevant for the development of gene therapy products; review and approve, as necessary, internal documentation to ensure conformance with regulations and existing regulatory approvals
  • Assess proposed manufac
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Valid through: 2020-5-19

About Blue Bird Corporation

Total Jobs:
84
Average Pay:
$147,469
Total value of jobs:
$12,240,000
% Masters:
71%
Learn More About Blue Bird Corporation
* Ladders Estimates

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