Immunovant, Inc. is a clinical-stage immunology company seeking a Senior Director, Regulatory Affairs Strategy to lead the development and execution of global regulatory strategies across complex development programs.
Requirements
- Bachelor’s degree in a scientific discipline required; advanced degree (Master’s or PhD) strongly preferred.
- Minimum of 12–15+ years of regulatory experience in the biopharmaceutical industry, with demonstrated progression in scope and complexity.
- Significant experience developing and executing global regulatory strategies for biologics across clinical development and, preferably, marketing applications.
- Demonstrated leadership in Health Authority interactions, including FDA and major ex‐US agencies.
- Strong understanding of global regulatory requirements, guidance, and processes (FDA, EMA, ICH, and other key regions).
- Experience leading or contributing to INDs and BLAs; MAA experience preferred.
- Proven ability to think strategically while remaining hands-on as needed.
- Excellent written and verbal communication skills, with the ability to influence senior leaders and cross-functional partners.
- Experience mentoring and developing regulatory talent in a matrixed, fast-paced environment.
- Comfort operating with ambiguity and shifting priorities in a high-growth biotech setting.
Benefits
- Medical
- Dental
- Vision
- 401k
- Unlimited paid time off
- Parental leave