Regulatory CMC Senior Manager

3 weeks ago

Waltham, Massachusetts, United States Deciphera Pharmaceuticals Full time
Job Description

Deciphera Pharmaceuticals, a biopharmaceutical company, is seeking a highly skilled Regulatory CMC Senior Manager to join its growing Post-Approval Group within the Regulatory Affairs Organization. The primary responsibility of this position is to lead and execute post-approval CMC regulatory activities in support of Deciphera's globally approved marketing applications.

This role will report to the Associate Director, Regulatory CMC and can be performed remotely within the US. The successful candidate will collaborate with cross-functional team members to plan, write, and review CMC sections of global regulatory submissions.

The ideal candidate will have a strong background in CMC Regulatory Affairs, with experience in leading the preparation of high-quality CMC regulatory submissions for global marketing and post-approval applications. They will also have a deep understanding of global regulatory guidelines, including FDA, EMA, and ICH.

The Regulatory CMC Senior Manager will be responsible for reviewing documentation in support of CMC and QA activities, assessing proposed CMC changes for global regulatory impact, and communicating with regulatory Health Authorities as needed.

This is an excellent opportunity for a seasoned professional to join a dynamic team and contribute to the success of Deciphera's regulatory affairs organization.

Key Responsibilities:

  • Lead and execute post-approval CMC regulatory activities in support of Deciphera's globally approved marketing applications.
  • Collaborate with cross-functional team members to plan, write, and review CMC sections of global regulatory submissions.
  • Review documentation in support of CMC and QA activities.
  • Assess proposed CMC changes for global regulatory impact.
  • Communicate with regulatory Health Authorities as needed.

Requirements:

  • B.S. in a scientific discipline required (degree in Chemistry strongly preferred); advanced degree a plus.
  • 6+ years pharmaceutical industry experience in CMC Regulatory Affairs.
  • Direct experience with global commercial programs strongly preferred.
  • Previous experience in leading the preparation of high-quality CMC regulatory submissions for global marketing and post-approval applications.
  • Strong knowledge in global regulatory guidelines, including FDA, EMA, and ICH.

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