Organizational Overview:
Immunovant is a publicly traded, clinical stage biopharmaceutical company committed to developing innovative therapies for patients living with autoimmune diseases. We are developing IMVT-1401, a novel, fully human anti-FcRn monoclonal antibody, as a subcutaneous injection for the treatment of multiple autoimmune diseases that are mediated by pathogenic IgG antibodies. Phase 2 clinical development is ongoing with Phase 3 preparations underway.
Key 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 and support 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.
- Provide hands-on leadership to the regulatory and manufacturing team in planning, preparing, and coordinating CMC documents submitted to global authorities in support of regulatory filings, such as INDs, BLAs, MAAs, CTAs/IMPDs, amendments, annual updates, briefing documents, and responses to Agency queries.
- 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.
- Communicate project updates and risks to senior management and stakeholders across the organization. Track regulatory commitments and deliverables. Interact efficiently and independently with consultants.
Requirements:
- Bachelor’s degree in a relevant scientific discipline and/or information technology. Advanced degree preferred
- 8+ years of biopharmaceutical experience, which includes at least 6 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 drug-device combination development.
- Comprehensive understanding of CMC product development with biologics and drug-device combinations and 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
Specialized knowledge, Licenses, etc.:
- 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 and drug-device combination development programs
- Commitment to company values and culture
- Proven ability to adapt to change and uncertainty as projects evolve
- Strong oral and written communicator
- Self-motivated, with initiative and the ability to take ownership of, and follow through with, specific tasks.
- Ability to multi-task and adjust priorities quickly while working under tight deadlines.
- Skilled in developing collaborative internal and external relationships.
- Strong PC experience and demonstrated proficiency in MS Office (Outlook, Word, Excel, PowerPoint, Project).
Work Environment:
- The position will be located in Immunovant’s NY office
- Dynamic, interactive, fast-paced, and entrepreneurial environment
- Domestic or international travel is required (~10%)