Immunovant is a clinical-stage biopharmaceutical company focused on enabling normal lives for patients with autoimmune diseases. Immunovant is developing IMVT-1401, a novel, fully human anti-FcRn monoclonal antibody, as a subcutaneous injection for the treatment of autoimmune diseases mediated by pathogenic IgG antibodies.
This highly dynamic team is seeking an entrepreneurial and strategic Director/Sr. Director, Regulatory Affairs CMC to play a key role on our cross-functional R&D team. In this role, you will partner with Immunovant's VP, Regulatory Affairs to lead and contribute to regulatory strategies that expedite development, maximize the probability of success, and mitigate risks. The individual in this position will have the unique opportunity to grow and shape the Regulatory function of a rapid-growth biotech startup.
KEY ROLES AND RESPONSIBILITIES:
- Lead and contribute to regulatory strategies that expedite development, maximize the probability of success, and mitigate risks. Ensure global CMC regulatory requirements and strategy are understood by project teams.
- Play a hands-on role in planning, preparing, and coordinating CMC documents for submission to global health authorities in support of regulatory filings, such as INDs, BLAs, MAAs, CTAs/IMPDs, amendments, annual updates, briefing documents, and responses to Agency queries.
- Partner and work very closely with internal and external cross-functional team members to ensure achievement of submission deadlines and timely approvals of CMC-related applications
- Lead interactions with FDA and other Health Authorities for CMC-related topics.
- Communicate project updates and risks to senior management and stakeholders across the organization. Track regulatory commitments and deliverables.
- Maintain up-to-date knowledge and understanding of global regulatory requirements.
- Initiate and contribute to the development of policies and procedures in alignment with GxPs, global regulatory requirements and guidance, and corporate objectives.
- 10+ years of biopharmaceutical experience, including at least 8 years of direct experience 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 devices
- Comprehensive understanding of CMC product development and in knowledge of applicable global regulations, guidance, and practices
- Experience in the preparation and submission of global regulatory dossiers (including IND/CTA/NDA/BLA/MAA), briefing documents, and agency queries
- Prior experience leading interactions with global regulatory authorities on CMC-related issues
- Strategic and analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines
- Strong leadership in working with multiple functional areas in a fast-paced matrixed team environment, including functional team members, company management, and external vendors and contract organizations
- Strong verbal and written communication skills; ability to clearly articulate regulatory viewpoints to diverse internal and external audiences including executive leadership
- Ability to thrive in a collaborative and fast-paced environment
- Results-oriented individuals with a strong work ethic and ability to complete projects with minimal oversight; track record of successful IND, CTA, NDA/BLA, and MAA submissions
- Knowledge of GxP, ICH, FDA, EMA and other global regulations and guidance
- Attention to detail and an ability to balance analytical and critical-thinking skills to develop data-driven, strategically oriented regulatory proposals and documents
- Strong experience leading regulatory CMC strategy and input for biologics development programs
- Bachelor's degree in a relevant scientific discipline; advanced degree (Master's or PhD) in relevant discipline preferred