Associate Director, Regulatory Affairs Strategy

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Immunovant

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2018

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

Healthcare • Biotechnology • Pharmaceuticals

Immunovant is a company focused on advancing treatments for autoimmune diseases through a patient-focused approach. With a vision of enabling normal lives for people with autoimmune diseases, Immunovant applies its expertise in science to develop and test new therapies. The company emphasizes complex and variable needs across different stages and severities of diseases. Immunovant is committed to pushing forward its therapeutic areas and clinical trials, while also engaging with patients, caregivers, and investors about their ongoing studies and corporate initiatives.

📋 Description

• Support and contribute to regulatory strategies that expedite development and maximize the probability of success • Help mitigate identified regulatory risks • Understand global regulatory requirements to support strategy • Collaborate to ensure regulatory strategy is understood by project teams • Plan, prepare, and coordinate regulatory documents for global health authority submissions, including INDs, BLAs, MAAs, CTAs/IMPDs, amendments, annual updates, briefing documents, and Agency query responses • Collaborate with internal and external cross-functional team members to achieve submissions and timely application approvals • Support interactions with FDA and other Health Authorities • Formulate communications of project updates and risks to senior management and organizational stakeholders • Track regulatory commitments, deliverables, and overall project timelines • Maintain current knowledge of global regulatory requirements • Contribute to policies and procedures aligned with GxPs, global regulatory requirements and guidance, and corporate objectives • Provide hands-on support to cross-functional teams preparing and coordinating regulatory submission documents

🎯 Requirements

• 8+ years of biopharmaceutical experience, including at least 4 years of direct Regulatory Affairs experience • Experience in biologics or small-molecule drug development, parenteral products including combination products, and orphan/rare disease product development • Experience supporting and implementing regulatory strategies in a global environment • Comprehensive understanding of applicable global regulations, guidance, and practices • Hands-on experience preparing and submitting global regulatory documents, including IND/CTA, NDA/BLA/MAA, briefing documents, Clinical Trial Applications, and Agency queries • Experience supporting interactions with FDA and other global regulatory authorities • Strong problem-solving skills and ability to adapt to changing priorities and deadlines • Ability to problem-solve regulatory issues and apply learnings • Ability to work collaboratively and efficiently across multiple functional areas in a fast-paced matrixed environment, including management, functional teams, external vendors, and contract organizations • Strong team and project management skills • Strong verbal and written communication skills • Results-oriented, 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; analytical and critical-thinking skills for data-driven regulatory proposals and documents • Experience supporting regulatory strategies for biologics and/or rare disease development programs • Commitment to company values and culture • Ability to adapt to change and uncertainty • Self-motivated, takes ownership, and follows through on tasks • Ability to multitask and adjust priorities under tight deadlines • Strong PC experience and proficiency in MS Office, including Outlook, Word, Excel, PowerPoint, and Project • Willingness to travel domestically or internationally 10–20% • Advanced Master’s degree in a relevant scientific discipline is preferred, not required

🏖️ Benefits

• Equity and other forms of compensation may be provided as part of a total compensation package • Medical benefits • Dental benefits • Vision benefits • 401k • Unlimited paid time off • Parental leave