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Braveheart Bio

(Senior) Director, Regulatory Affairs CMC

Who can apply: Only open to applicants in: California.
Location as listed by the employer: “San Francisco, CA or Remote or Hybrid”
Apply on Braveheart Bio's site ↗

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About this role

Braveheart Bio is hiring for a (Senior) Director, Regulatory Affairs CMC role. See the official posting for full details.

Requirements

  • Bachelor's degree required; advanced degree in a life science, pharmaceutical science, or related field (PhD, PharmD, or MS) preferred.
  • A minimum of 12 years in Regulatory Affairs CMC, including serving as the CMC Regulatory Lead for late-stage or commercial products.
  • Hands-on experience authoring and reviewing CMC sections for INDs/CTAs and marketing applications (NDAs/MAAs)
  • Direct experience supporting commercial readiness, including process validation/PPQ, launch supply, and pre-approval inspection preparation.
  • Experience with technology transfer and site-to-site comparability
  • Experience overseeing CDMOs from a CMC regulatory perspective.
  • Experience with small-molecule drug substance and drug product CMC (oral solid dose experience preferred)
  • Experience leading CMC-related interactions and meetings with FDA and other health authorities.

Summarized from the employer's posting — check the full posting for every requirement.