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Director, Regulatory Affairs CMC

$207k - $253k
Full-time

Madrigal Pharmaceuticals

Waltham, MA

Madrigal Pharmaceuticals seeks a Director of Regulatory Affairs CMC to lead chemistry, manufacturing, and controls strategies for clinical and commercial products. The role involves developing regulatory submission strategies, representing the company in health authority meetings, and managing CMC compliance and risk across the product lifecycle.

Responsibilities

  • Independently develop and execute regulatory CMC strategies for investigational, registration, and post-approval submissions
  • Apply regulatory expertise to resolve CMC challenges during product development and commercialization
  • Guide team in defining dossier content strategy and ensure compliance with health authority requirements
  • Represent regulatory CMC function in health authority meetings and lead preparation activities
  • Monitor global CMC regulatory requirements, guidelines, and emerging trends; communicate relevant updates

Requirements

  • Bachelor's degree in life sciences or healthcare field; advanced degree strongly preferred
  • Minimum 12 years relevant experience with 8-10 years in regulatory CMC
  • Strategic CMC experience with small molecule products through clinical and commercialization phases
  • Demonstrated experience interacting with global health authorities on CMC matters
  • Strong knowledge of global regulations and guidelines governing pharmaceutical CMC development
  • Excellent communication and negotiation skills with ability to engage technical experts and regulatory agencies

Compensation: $207,000-$253,000 per year

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Vacancy posted 7 hours ago
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