Organizational Overview:
Immunovant is a clinical-stage biopharmaceutical company with a company vision focused on enabling normal lives for patients with autoimmune diseases. Our lead asset, IMVT-1401, is a novel, fully-human, anti-FcRn monoclonal antibody in clinical development for multiple indications, delivered as a subcutaneous injection for the treatment of autoimmune diseases mediated by pathogenic IgG antibodies. Immunovant is committed to developing innovative therapies that not only treat the symptoms but modify the course of autoimmune diseases, while restoring hope and health to patients with autoimmune disease by developing and delivering high-value restorative therapies that enable them to live normal lives.
The Role:
This newly created role within the Regulatory Affairs organization is an exciting opportunity for a seasoned Regulatory Affairs professional to serve as a leader in the oversight and optimization of multiple groups within the Regulatory Affairs department. The VP of Regulatory Affairs Operational Excellence reports to the Senior Vice President of Regulatory Affairs and will be responsible for overseeing the following Regulatory groups:
The ideal candidate will have subject matter knowledge in the above Regulatory arenas. S/He should have a proven track record of managing multiple functions and people with the discretion to appropriately prioritize initiatives and needs of their teams, groups, and individuals in a fast-paced and dynamic environment. This position will need to have strong relationships across all functions associated with document content writing, management, and retention requirements. This position will drive operational transformation to accommodate near- and long-term corporate objectives that require Regulatory operational foresight. S/He will review clinical/regulatory documents to support all phases of drug development by leading MW project management activities of an interdisciplinary team to ensure documents are strategic, high quality, and comply with internal and external standards. S/He will delegate workplans for ongoing initiatives as appropriate, and provide leadership and strategic support for the team responsible for development and implementation.
Key Responsibilities:
Requirements:
Work Environment:
Compensation is based on a number of factors including market location and may vary depending on job-related knowledge, skills, and experience. Equity, sign-on bonuses, 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. The annual base salary for this position ranges from $320,000.00 – $340,000.00.