Regulatory CMC Director

This growing biopharma company develops innovative small molecule drugs for the treatment of cancer and other serious diseases.  They are anticipating approval of their first NDA this month and they just filed their second NDA in December!  They are seeking a Regulatory CMC Director to lead regulatory CMC strategy and execution for a portfolio of early and late stage programs.  You will oversee the preparation and submission of high-quality CMC sections of INDs, CTAs, and NDAs while also supporting post-approval CMC activities for future marketed products. This company offers a collaborative patient-focused culture, excellent benefits, a soaring stock price, and tremendous growth opportunity.  Now is an exciting time to join this rapidly growing organization and make a difference in patient’s lives! 

Responsibilities:

  • Provide Regulatory CMC leadership and execution for a portfolio of early- and late-stage development programs, as well as future marketed products.
  • Work closely with cross-functional stakeholders, including colleagues in Regulatory Strategy, Pharmaceutical Sciences, and GMP QA, as well as external development and manufacturing partners.
  • Lead and manage the preparation of high-quality CMC sections for INDs/CTAs/IMPDs, NDAs/MAAs, amendments, and supplements
  • Respond to information requests from health authorities, and prepare briefing documents for regulatory agency interactions.
  • Ensure that CMC submissions are complete and meet applicable regulatory requirements.
  • Lead CMC regulatory intelligence activities, monitoring guidelines and trends, interpreting CMC regulations and guidance documents, and providing regulatory advice to in-house CMC and project teams.
  • Work with internal teams to assess proposed manufacturing changes, providing strategic regulatory guidance and define reporting requirements.
  • Conduct risk assessments and develop mitigation strategies for CMC regulatory matters.
  • Support on-site regulatory inspections as a Subject Matter Expert.
  • Occasional travel may be required.

 

Knowledge and Skills:

  • Bachelor’s degree in a scientific discipline; advanced degree (MS or Ph.D.) preferred.
  • 10+ years of relevant industry experience with 5+ years in Regulatory CMC for small molecule drugs.
  • Successful track record in CMC submissions to regulatory agencies (IND, CTA, NDA, etc)
  • Experience in interacting with FDA and other regulatory authorities required
  • Strong knowledge of current Good Manufacturing Practices as well as drug development guidelines and regulations (ICH, FDA, and EMA).
  • Ability to lead, motivate, and engage others to ensure successful delivery of projects.
  • Strong interpersonal, project management, and organizational skills.
  • Excellent technical-regulatory writing and oral communication skills.
  • Must be collaborative, disciplined, innovative, open-minded, patient-focused, and resilient.

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