Director, Global Regulatory Affairs
Zenas BioPharma(1 month ago)
About this role
The Director, Regulatory Affairs leads regulatory activities for early and late-stage investigational products and serves as a strategic regulatory partner across the organization. This role oversees preparation and submission of IND/CTA and future marketing applications, provides regulatory intelligence, and supports compliant global development programs. The position reports to the Executive Director, Global Regulatory Affairs and participates on cross-functional teams to align regulatory strategy with program objectives.
Required Skills
- Regulatory Strategy
- Team Leadership
- Submission Writing
- IND CTA
- NDA MAA
- Regulatory Intelligence
- SOP Authoring
- CRO Management
- Cross-Functional Collaboration
- Budgeting
+3 more
Qualifications
- BS in Life/Physical Sciences
- Advanced Degree in Life/Physical Sciences
About Zenas BioPharma
zenasbio.comZenas 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.
Apply instantly with AI
Let ApplyBlast auto-apply to jobs like this for you. Save hours on applications and land your dream job faster.
More jobs at Zenas BioPharma
Similar Jobs
Director, Regulatory Affairs
Neumora(1 month ago)
Associate Director, Regulatory Affairs
Maze Therapeutics(1 month ago)
Senior Director, Clinical Regulatory Affairs
Umoja Biopharma(12 days ago)
Director, Regulatory Affairs
Regenxbio(1 month ago)
Senior Manager, Regulatory Affairs
Maze Therapeutics(1 month ago)
Manager Regulatory Affairs
Beam Therapeutics(1 month ago)