Global Regulatory CMC Manager or Sr. Manager

This client is an established, global biopharmaceutical company with multiple approved products and a strong pipeline.  They are seeking a Global Regulatory CMC Scientist (Manager or Sr. Manager level) to develop and execute global regulatory CMC submission plans for assigned biologic development projects and/or marketed products. You will partner with cross functional teams to lead all aspects of CMC submissions including INDs, CTAs, BLAs, and supplements.

Responsibilities:

  • Collaborate with multi-disciplinary teams, prepare the CMC section of INDs, BLAs, CTAs, CTDs, amendments, supplements and annual reports, including the compilation and review of the required data, scientific reports.
  • Assist in preparation of risk analyses and contingency plans for CMC regulatory strategies and dossiers.
  • Work with cross-functional teams for assigned projects to set objectives for HA meetings, lead interactions and oversee preparation responses.
  • Provide regulatory CMC guidance to ensure development activities are aligned with relevant health authority regulations and in line with current global guidance.
  • Guide manufacturing in developing data for approval of post-marketing changes.

 

Knowledge and Skills:

  • Bachelor Degree in a scientific discipline; advanced degree preferred.
  • At least 4 years of pharmaceutical industry experience, with a minimum of 2 years of experience in Regulatory CMC.
  • Experience in the preparation of CMC sections for US INDs and marketing applications; experience with EU CTAs, MAAs, and/or global applications strongly preferred.
  • Regulatory CMC experience with biologic programs preferred.
  • Broad knowledge of global biotech CMC guidances and regulations.
  • Ability to handle tasks and projects independently.
  • Excellent interpersonal skills and ability to establish and maintain relationships with various intra-department, inter-department, and external third party personnel.

 

NOTE:  Qualified candidates must be legally authorized to be employed in the United States. Client cannot support an H1B transfer.

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