Senior Director CMC Regulatory Affairs

<div class="content-intro"><p>Immunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. As trailblazer in anti-FcRn technology, the Company is developing innovative, targeted therapies to meet the complex and variable needs of people with autoimmune diseases.</p></div><p><strong>The Role:</strong></p> <p>Reporting to the Senior Vice President, Global Regulatory Affairs, this position is responsible for …</p> <p><strong>Key Responsibilities: </strong></p> <ul> <li>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.</li> <li>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.</li> <li>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</li> <li>Lead and support interactions with FDA and other Health Authorities for CMC-related topics.</li> <li>Communicate project updates and risks to senior management and stakeholders across the organization. Track regulatory commitments and deliverables.</li> <li>Maintain up-to-date knowledge and understanding of global regulatory requirements.</li> <li>Initiate and contribute to the development of policies and procedures in alignment with GxPs, global regulatory requirements and guidance, and corporate objectives.</li> <li>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.</li> </ul> <ul> <li>Ability to communicate with CMC management and leadership on CMC creative filing strategies, summarize regulatory strategy and associated risks in a collaborative manner.</li> </ul> <ul> <li>Strong stakeholder partnership with Quality, project management, supply chain and CMC to enable open and robust discussions to achieve the best scientific decisions.</li> <li>Communicate project updates and risks to senior management and stakeholders throughout the organization. Track regulatory commitments and deliverables.  Interact effectively and independently with consultants.</li> <li>Ability to establish an integrated CMC regulatory strategy that anticipates risk, aligns with enterprise objectives, and secures cross-functional alignment across Technical Operations, Quality, and Program leadership.</li> <li>Leadership across CMC strategy and supervision. Expected to manage the CMC team and contractors supporting work, along with coaching and mentoring of the staff.</li> </ul> <p><strong> </strong></p> <p><strong>Requirements:</strong></p> <ul> <li>Masters or PhD degree in a relevant scientific discipline, Advanced degree preferred</li> <li>12+ years of biopharmaceutical experience, which includes at least 6 years of direct experience in Regulatory Affairs CMC</li> <li>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.</li> <li>Comprehensive understanding of CMC product development with biologics and drug-device combinations and knowledge of applicable global regulations, guidance, and practices</li> <li>Experience in the preparation and submission of global regulatory dossiers (including IND/CTA/NDA/BLA/MAA), briefing documents, and agency queries. Recent and relevant BLA filing experiences.</li> <li>Prior experience leading interactions with global regulatory authorities on CMC-related issues</li> <li>Strategic and analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines</li> <li>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</li> <li>Strong verbal and written communication skills; ability to clearly articulate regulatory viewpoints to diverse internal and external audiences including executive leadership</li> <li>Ability to thrive in a collaborative and fast-paced environment</li> </ul> <p> </p> <p>Specialized knowledge, Licenses, etc.:</p> <ul> <li>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</li> <li>Knowledge of GxP, ICH, FDA, EMA and other global regulations and guidance</li> <li>Attention-to-detail and an ability to balance analytical and critical-thinking skills to develop data-driven, strategically oriented regulatory proposals and documents</li> <li>Strong experience leading regulatory CMC strategy and input for biologics and drug-device combination development programs</li> </ul> <p><strong> </strong></p> <p><strong>Work Environment:</strong></p> <ul> <li>Remote-based</li> <li>Dynamic, interactive, fast-paced, and entrepreneurial environment</li> <li>Domestic or international travel are required (10-20%)</li> </ul> <p> </p> <p> </p><div class="content-pay-transparency"><div class="pay-input"><div class="title">Salary range for posting</div><div class="pay-range"><span>$260,000</span><span class="divider">—</span><span>$295,000 USD</span></div></div></div><div class="content-conclusion"><p>Compensation is based on a number of factors, including market location, and may vary depending on job-related knowledge, skills, and experience. Equity and other forms of compensation may be provided as part of a total compensation package, in addition to a full range of medical, dental, vision, 401k, and other benefits, including unlimited paid time off and parental leave.</p> <p> </p></div>