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Associate Director/Director Regulatory Affairs CMC

  • Location


  • Sector:

    Life Sciences

  • Job type:


  • Contact:

    Antoinette Miller

  • Contact email:

  • Salary high:


  • Salary low:


  • Published:

    14 days ago

  • Expiry date:


  • Startdate:


Our client is a clinical-stage biotechnology company focused on creating and developing engineered antibodies. The company's antibodies have inherent properties that they believe may enable them to improve upon the efficacy and safety of specific antibodies in multiple therapeutic applications.

They have created a proprietary antibody technology platform that they believe is particularly well suited for developing T cell engagers, receptor cross-linking agonists, and targeted cytokines. Their lead product candidate is a bispecific T cell engaging  antibody targeting CD20 and CD3, and have initiated a Phase 1 clinical trial for the treatment of Non-Hodgkin's lymphoma (NHL) patients in 2019. Their second product candidate is for the treatment of patients with solid and hematologic malignancies, for which they have recently initiated a Phase 1 clinical trial.  Also, in their product pipeline is a bispecific antibody delivering cytokines to expressing cells for the treatment of patients with solid and hematologic malignancies.


As Associate Director/Director, Regulatory Affairs CMC you will be responsible for developing, leading, and implementing global regulatory CMC strategies in collaboration with key internal stakeholders for the company's growing pipeline of programs. This position will initially be an individual contributor with the potential to hire and manage additional staff over time and will report to the VP of regulatory affairs.  The opportunity to learn clinical aspects of regulatory affairs will also be an option for candidates with interest in this area.