Job Description
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.
The Role:
Reporting to the Senior Vice President, Global Regulatory Affairs, this position is responsible for …
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.
Ability to communicate with CMC management and leadership on CMC creative filing strategies, summarize regulatory strategy and associated risks in a collaborative manner.
Strong stakeholder partnership with Quality, project management, supply chain and CMC to enable open and robust discussions to achieve the best scientific decisions.
Communicate project updates and risks to senior management and stakeholders throughout the organization. Track regulatory commitments and deliverables. Interact effectively and independently with consultants.
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.
Leadership across CMC strategy and supervision. Expected to manage the CMC team and contractors supporting work, along with coaching and mentoring of the staff.
Requirements:
- Masters or PhD degree in a relevant scientific discipline, Advanced degree preferred
- 12+ 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. Recent and relevant BLA filing experiences.
- 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
Work Environment:
- Remote-based
- Dynamic, interactive, fast-paced, and entrepreneurial environment
- Domestic or international travel are required (10-20%)
Salary range for posting
$260,000—$295,000 USD
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.
