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Director, Regulatory Affairs CMC

🕒 2 days ago
CMC Regulatory AffairsSmall Molecule Drug DevelopmentIND PreparationNDA Submissions

📜 Description

  • Manages the CMC regulatory affairs activities for marketed products and compounds in development in line with US and ex-US regulatory requirements
  • Coordinates with R&D, Pharmaceutical Development, Manufacturing, Quality and Regulatory colleagues and other functional areas to develop and implement CMC regulatory strategy
  • Manages the timely preparation of high quality CMC sections of INDs, CTAs, NDAs, MAAs and amendments for submission to regulatory authorities supporting the conduct of clinical trials and marketing applications worldwide
  • Contributes as a key regulatory representative with external parties and acts as a point of contact with regulatory agencies for CMC development, product registration, and life-cycle activities
  • Supports the regulatory function on development

🛠️ Requirements

  • Coordinates with R&D, Pharmaceutical Development, Manufacturing, Quality and Regulatory colleagues and other functional areas to develop and implement CMC regulatory strategy
  • Manages the timely preparation of high quality CMC sections of INDs, CTAs, NDAs, MAAs and amendments for submission to regulatory authorities supporting the conduct of clinical trials and marketing applications worldwide
  • Contributes as a key regulatory representative with external parties and acts as a point of contact with regulatory agencies for CMC development, product registration, and life-cycle activities
  • Supports the regulatory function on development

Benefits

  • New hire and ongoing equity packages
  • Medical
  • Dental
  • Vision insurance
  • Employer-paid life
  • Business travel and EAP coverage
  • 15+ vacation days
  • 13 -15 paid holidays, including office closure between December 24th and January 1st
  • 10 days of paid sick time
  • Paid parental leave benefit
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