Associate Director, Regulatory Affairs Strategy

About the Company

Immunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. As a trailblazer in anti-FcRn technology, the Company is developing innovative, targeted therapies to meet the complex and variable needs of people with autoimmune diseases.

Responsibilities

• Support and contribute to innovative global regulatory strategies to expedite development and maximize success
• Mitigate identified regulatory risks and ensure strategies are understood by project teams
• Plan, prepare, and coordinate regulatory documents for submission to global health authorities (INDs, BLAs, MAAs, CTAs/IMPDs, etc.)
• Support interactions with the FDA and other global Health Authorities
• Collaborate with internal and external cross-functional teams to ensure timely application approvals
• Formulate communications regarding project updates and risks for senior management
• Track regulatory commitments, deliverables, and project timelines
• Contribute to the development of policies and procedures in alignment with GxPs and global guidance

Requirements

• 8+ years of biopharmaceutical experience with at least 4 years in Regulatory Affairs
• Experience in biologics, small molecule drug development, parenteral products, or orphan/rare disease development
• Demonstrated hands-on experience preparing and submitting global regulatory documents (IND/CTA, NDA/BLA/MAA)
• Prior experience supporting interactions with FDA and other global regulatory authorities
• Comprehensive understanding of global regulations, including GxP, ICH, FDA, and EMA
• Strong project management and communication skills
• Ability to work in a fast-paced, matrixed team environment

Preferred Qualifications

• Advanced degree (Master's) in a relevant scientific discipline