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.
Reporting to the Chief Medical Officer, the VP of Regulatory Affairs will be responsible for leading a small yet very high functioning team and driving the development and implementation of global regulatory strategies and worldwide submissions for Immunovant’s development programs. The incumbent will provide leadership for the team responsible for planning and executing program applications, both in the US and ex-US, and will hold accountability for regulatory submissions, applicable communications, and GXP compliance across the company’s programs. S/he will focus on corporate goals while responding to the needs of project teams in a highly dynamic fast-moving environment. Beyond that, the VP will assess the current infrastructure and plan to build the team out as business dictates.
- Lead the function by generating strategic regulatory options and then implementing along with the team with a hands-on approach in order to expedite development, maximize the probability of success, and mitigate risks; effectively partner cross-functionally in order to ensure regulatory requirements and strategy are understood by the project teams.
- Ability to research, author, review, and submit high-quality documentation for INDs, CTAs, BLAs, and MAAS, and related filings to regulatory agencies within established timeframes.
- Coordinate the preparation of responses to questions/information requests from US and ex-US regulatory agencies
- Act as the primary regulatory representative at internal meetings as well as meetings with business partners and US and ex-US regulatory agencies
- Assess and communicate regulatory requirements to ensure all development activities are in compliance with applicable regulations and guidelines, including IND/NDA maintenance requirements
- Monitor changes to development plans and provide regulatory guidance to teams to bridge changes into the clinic
- Obtain and disseminate information regarding current activities, trends, and changes in the regulatory environment
- Be familiar with CMC regulatory issues and liaise with the appropriate US and ex-US CMC regulatory experts, as needed
- Function as a regulatory strategist with extensive ability to analyze complex situations and develop relevant and realistic plans with appropriate risk mitigation strategies
- Foster the growth and development and provide mentorship for the regulatory affairs team
- Proven success in delivering effective global regulatory strategies in coordination with clinical plans and marketing objectives leading to successful registration.
- Both IND and BLA experience required.
- Responsibilities will include original applications and product maintenance, such as information amendments and annual reports.
- Expertise in working with global regulatory authorities; specifically communicating and negotiating with FDA and other global regulatory agencies.
- Understanding of policy, laws, regulations, and guidelines as they apply to Regulatory Agencies for drug development and approval.
- Bachelor’s degree in a scientific discipline required; advanced degree highly desired
- Minimum 10 years regulatory industry experience in biopharmaceuticals
- Experience with defining strategy, preparing and submitting US and ex-US marketing applications, and conducting direct interactions and negotiations with regulatory agencies (US, ex-US).
- Previous experience in leading submission teams for clinical trial and marketing applications
- In-depth understanding of regulatory processes, procedures, guidelines, US / Global regulatory strategy and ability to integrate into company-wide goals
- Experience in presenting information at internal and external meetings, and regulatory agency meetings.
- Strong knowledge of eCTD elements and structure with regulatory writing skills
- Strong knowledge of drug development, FDA, EMA and other guidelines and regulations
- Knowledge of current Good Manufacturing Practices (cGMP)
- Experience with Chemistry, Manufacturing and Control (CMC) related regulatory matters
- Knowledge of promotional regulatory review requirements
- Excellent attention to detail and problem-solving skills
- Effective written and verbal communication skills required
- Ability to work in a small, fast-paced environment covering a range of activities from document creation to high level agency interactions as the need arises
- Demonstrated experience with effective management of contract employees, consultants and direct reports
- Dynamic, interactive, fast-paced, and entrepreneurial environment
- Immunovant’s headquarters is located in New York City. The position is flexible for remote work.
- Domestic travel required (up to 10%)