Organizational Overview:

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:

This highly dynamic team is seeking a motivated and entrepreneurial Associate Director, Regulatory Affairs Strategy, to play a key role on our cross-functional R&D team. In this role, you will be responsible for supporting and contribute to innovative global regulatory strategies that expedite development, maximize the probability of success, identify regulatory opportunities, and mitigate risks. The individual in this position will have the unique opportunity to grow and mentor regulatory scientists on regulatory requirements and regulatory environmental trends, as well as help shape the regulatory approach in a rapid-growth biotech startup.

Key Responsibilities: 

• Support and contribute to regulatory strategies that expedite development and maximize the probability of success based on knowledge of regulatory environment.
• Help mitigate identified regulatory risks.
• Understand global regulatory requirements to support strategy.
• Collaborate to ensure regulatory strategy is understood by project teams.
• Play a hands-on role in planning, preparing, and coordinating regulatory 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.
• Close collaboration with internal and external cross-functional team members to ensure the achievement of submissions and timely approvals of applications.
• Support interactions with FDA and other Health Authorities.
• Help formulate communications of project updates and risks to senior management and stakeholders across the organization.
• Track regulatory commitments, deliverables, and overall project timelines.
• Maintain up-to-date knowledge and understanding of global regulatory requirements.
• Contribute to the development of policies and procedures in alignment with GxPs, global regulatory requirements and guidance, and corporate objectives.
• Provide hands-on support to cross-functional teams in planning, preparing, and coordinating documents for submission 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.

Requirements

• 8+ years of biopharmaceutical experience, which includes at least 4 years of direct experience in Regulatory Affairs.
• An advanced degree (Master’s) in a relevant scientific discipline is preferred.
• Experience in biologics or small molecule drug development, parenteral products, including combination products, and orphan/rare disease product development.
• Experience in supporting and implementing regulatory strategies in a global environment.
• Comprehensive understanding of applicable global regulations, guidance, and practices.
• Demonstrated hands-on experience in the preparation and submission of global regulatory documents, including clinical trial applications and maintenance (IND/CTA), NDA/BLA/MAA, briefing documents, Clinical Trial Applications, and Agency queries.
• Prior experience in supporting interactions with FDA and other global regulatory authorities.
• Excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
• Ability to problem-solve regulatory issues and apply learnings.
• Works collaboratively and efficiently with multiple functional areas in a fast-paced matrixed team environment, including functional team members, company management, and external vendors and contract organizations.
• Strong team and project management skills
• Strong verbal and written communication skills.
• Results-oriented individual with a strong work ethic and ability to complete projects with oversight.
• 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 support data-driven, strategically oriented regulatory proposals and documents.
• Experience supporting regulatory strategies for biologics and/or rare disease development programs.
• Commitment to company values and culture.
• Proven ability to adapt to change and uncertainty as projects evolve.
• 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.
• Strong PC experience and demonstrated proficiency in MS Office (Outlook, Word, Excel, PowerPoint, Project).

 Work Environment:

• Remote-based
• Dynamic, interactive, fast-paced, and entrepreneurial environment
• Domestic or international travel is required (10-20%)