Senior Director, Regulatory Affairs CMC

Zenas BioPharma(4 days ago)

HybridFull TimeDirector$220,000 - $275,000Regulatory Affairs

About this role

The Sr. Director, Regulatory Affairs CMC at Zenas is a senior regulatory leader responsible for overseeing global CMC regulatory strategy to support clinical development of small molecule drug products. The role sits within the Regulatory Affairs organization and partners with Technical Operations, Quality and other stakeholders, reporting to the Vice President, Global Regulatory Affairs CMC. Zenas is a clinical-stage biopharmaceutical company focused on developing therapies for autoimmune diseases.

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Required Skills

Regulatory Strategy
CMC
IND/IMPD
NDA Submissions
Module 3
Small Molecule
Chemistry Development
Regulatory Compliance
Cross-Functional Leadership
Technical Writing

Qualifications

BS in Chemistry or Life Sciences
Advanced Degree

About Zenas BioPharma

zenasbio.com

Zenas BioPharma is a biotechnology company focused on discovering and developing therapies for autoimmune and inflammatory diseases. Their stated mission is “Enabling patients with autoimmune diseases to reimagine life,” and they concentrate on finding I&I (inflammation & immunology) innovations. Zenas advances novel drug candidates through discovery and development with the goal of bringing new treatment options to patients and partnering across the biopharma ecosystem.