Similar Jobs
See allAssociate Director, Regulatory Affairs Strategy
Immunovant, Inc.
US
Regulatory Affairs
Drug Development
Project Management
Director, CMC Regulatory Affairs
Jade Biosciences
US
Regulatory Affairs
CMC
Biologics
Associate Director, Regulatory Affairs
Iovance Biotherapeutics
US
Regulatory Affairs
Cross-functional Leadership
Written Communication
Regulatory Manager
Precision Medicine Group
US
Regulatory Affairs
Clinical Trials
Drug Development
Director, Regulatory Affairs, CMC
Brainchild Bio
US
Regulatory Affairs
CMC
Cell Therapy
The Impact You’ll Make:
- Lead regulatory strategy for global development of products through all stages, from IND to post-approval.
- Manage complex issues, coordinate multiple projects, and practice sound judgment in risk assessment.
Your Team:
- Report to the Vice President, Regulatory, and collaborate with toxicology, pharmacology, and clinical development.
- Work in a global team environment to deliver regulatory strategies for assigned programs.
Experience You’ll Need:
- Minimum 10 years in pharma, with 8+ years in Global Regulatory Affairs and experience with major health authorities.
- Strong background in regulatory submissions (INDs, NDAs, MAAs, PIPs, ODDs, etc.) and cross-functional management.
Values We Hope You Share:
- Act boldly with integrity, care deeply, learn actively, take ownership, and collaborate as One Recursion.
Recursion
Recursion is a clinical-stage TechBio company that uses AI and technology to decode biology and accelerate drug discovery and development. The company employs hundreds across multiple global offices and values integrity, collaboration, and bold action.