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Regulatory CMC Manager

2 months ago

Waltham Massachusetts, United States Deciphera Pharmaceuticals Full time
Job Summary

We are seeking a highly skilled Manager, Regulatory CMC to lead our Post-Approval Group within the Regulatory Affairs Organization at Deciphera Pharmaceuticals. The successful candidate will be responsible for executing post-approval CMC regulatory activities in support of our globally approved marketing applications.

Key Responsibilities
  • Collaborate with cross-functional team members to plan, write, and review CMC sections of global regulatory submissions.
  • Provide regulatory guidance on post-approval content of Module 2/Module 3.
  • Review documentation in support of CMC and QA activities for small molecule commercial programs.
  • Assess proposed CMC changes for global regulatory impact and post-approval filing requirements.
  • Communicate with regulatory Health Authorities on project-related matters.
Requirements

The ideal candidate will have a strong understanding of global regulations and experience in CMC regulatory affairs. They will be able to provide expert guidance and support to cross-functional teams and communicate effectively with regulatory authorities.

Deciphera Pharmaceuticals is a dynamic and growing company, and we offer a competitive compensation package and opportunities for professional growth and development.