Senior Director - CMC Regulatory Affairs

1w1 week ago

Immunovant, Inc.

Full-time · $260,000 – $295,000

About this role

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, it develops innovative, targeted therapies for autoimmune needs. Reporting to the Senior Vice President, Global Regulatory Affairs, this role leads CMC regulatory strategies.

This position involves hands-on planning, preparing, and coordinating CMC documents for global submissions like INDs, BLAs, MAAs, CTAs/IMPDs, amendments, and agency responses. It ensures global CMC requirements are understood by project teams to expedite development and mitigate risks. Daily work focuses on achieving submission deadlines and timely approvals.

Collaborate closely with internal and external cross-functional teams, including Quality, project management, supply chain, and CMC groups. Lead interactions with FDA and other Health Authorities on CMC topics. Foster strong stakeholder partnerships for robust scientific decisions.

Communicate project updates, risks, and regulatory strategies to senior management across the organization. Track commitments and deliverables while maintaining up-to-date knowledge of global requirements. Initiate policies aligned with GxPs, regulations, and corporate objectives.

Provide hands-on leadership to the regulatory and manufacturing team, managing CMC staff and contractors. Coach and mentor team members while establishing integrated strategies aligned with enterprise goals. Drive CMC creative filing strategies in a collaborative manner.

Requirements

Master's or PhD degree in a relevant scientific discipline, advanced degree preferred
12+ years of biopharmaceutical experience, including at least 6 years in Regulatory Affairs CMC
Demonstrated hands-on experience in biologics drug development, registration, and post-approval life cycle management in a global environment
Direct involvement with parenteral products, including drug-device combination development
Comprehensive understanding of CMC product development with biologics and drug-device combinations and knowledge of global regulations
Experience in preparation and submission of global regulatory dossiers including IND/CTA/NDA/BLA/MAA, briefing documents, and agency queries; recent BLA filing experience
Ability to communicate CMC creative filing strategies and associated risks collaboratively with management
Strong stakeholder partnerships with Quality, project management, supply chain, and CMC for scientific decisions

Responsibilities

Lead and contribute to regulatory strategies that expedite development, maximize success probability, and mitigate risks
Plan, prepare, and coordinate CMC documents for submissions to global health authorities, including INDs, BLAs, MAAs, CTAs/IMPDs, amendments, annual updates, briefing documents, and agency queries
Partner closely with internal and external cross-functional teams to achieve submission deadlines and timely approvals of CMC applications
Lead and support interactions with FDA and other Health Authorities for CMC-related topics
Communicate project updates and risks to senior management and stakeholders; track regulatory commitments and deliverables
Maintain up-to-date knowledge of global regulatory requirements
Initiate and contribute to development of policies and procedures aligned with GxPs, global regulations, and corporate objectives
Provide hands-on leadership to regulatory and manufacturing team; manage CMC team and contractors, including coaching and mentoring