Similar Jobs
See allAssociate Director, Regulatory Affairs
Iovance Biotherapeutics
Regulatory Affairs
Oncology
Health Authority Interactions
Associate Director of Regulatory Affairs, CMC
Unknown
US
Regulatory Affairs
CMC
Cell Therapy
Head of Regulatory Affairs
ARTBIO
US
Regulatory Strategy
Drug Development
FDA Regulations
Senior Director, Regulatory Strategy – Global Regulatory Lead
Beeline Medicines
US
Regulatory Strategy
Project Management
Leadership
Associate Director, Regulatory Affairs
Zai Lab Limited
Global
Regulatory Affairs
Clinical Development
Health Authority Interactions
Role Summary:
- This fully remote role leads U.S. and global regulatory strategy for innovative oncology biologic programs.
- You will shape development pathways and submission plans for cell and gene therapies.
Key Accountabilities:
- Develop and execute U.S. and global regulatory strategies for assigned programs.
- Prepare and manage Clinical Trial Applications, Marketing Applications, and regulatory amendments.
- Lead health authority interactions and cross-functional regulatory planning.
Candidate Requirements:
- Bachelor's degree in life sciences with 5+ years of regulatory affairs experience (or equivalent).
- Late-stage oncology drug development experience and knowledge of biologics or advanced therapies.
- Strong communication, organizational, and strategic negotiation skills.
Why This Role:
- Opportunity to work fully remotely with global health authority exposure.
- Collaborate with cross-functional leaders on innovative oncology therapies.
N/A
A partner company is seeking a strategic regulatory affairs leader to support innovative oncology biologic and cell/gene therapy development programs. The company offers a fully remote environment with global regulatory exposure and cross-functional collaboration.