Immunovant is a clinical stage biopharmaceutical company committed to developing innovative therapies that not only treat the symptoms, but modify the course, of autoimmune diseases. Our lead asset, IMVT-1401, is in phase 2 clinical development for the treatment of multiple autoimmune diseases, with additional trials expected to start this year.
This highly dynamic team is seeking an entrepreneurial & strategic Director/Sr. Director, Regulatory Affairs CMC to play a key role on our cross-functional R&D team. In this role, you will partner with Immunovant's VP, Regulatory Affairs to lead & contribute to regulatory strategies that expedite development, maximize the probability of success, & mitigate risks. The individual in this position will have the unique opportunity to grow & shape the Regulatory function of a rapid-growth biotech startup.
Key Roles & Responsibilities:
- Lead & contribute to regulatory strategies that expedite development, maximize the probability of success, & mitigate risks. Ensure global CMC regulatory requirements & strategy are understood by project teams.
- Play a hands-on role in planning, preparing, & 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, & responses to Agency queries.
- Partner & work very closely with internal & external cross-functional team members to ensure achievement of submission deadlines & timely approvals of CMC-related applications
- Lead interactions with FDA & other Health Authorities for CMC-related topics.
- Communicate project updates & risks to senior management & stakeholders across the organization. Track regulatory commitments & deliverables.
- Maintain up-to-date knowledge & understanding of global regulatory requirements.
- Initiate & contribute to the development of policies & procedures in alignment with GxPs, global regulatory requirements & guidance, & corporate objectives.
- 10+ years of biopharmaceutical experience, including at least 8 years of direct experience in Regulatory Affairs CMC
- Demonstrated hands-on experience in biologics drug development, registration, & post-approval life cycle management in a global environment; direct involvement with parenteral products, including devices
- Comprehensive understanding of CMC product development & in knowledge of applicable global regulations, guidance, & practices
- Experience in the preparation & submission of global regulatory dossiers (including IND/CTA/NDA/BLA/MAA), briefing documents, & agency queries
- Prior experience leading interactions with global regulatory authorities on CMC-related issues
- Strategic & analytical thinker with excellent problem-solving skills & the ability to adapt to changing priorities & deadlines
- Strong leadership in working with multiple functional areas in a fast-paced matrixed team environment, including functional team members, company management, & external vendors & contract organizations
- Strong verbal & written communication skills; ability to clearly articulate regulatory viewpoints to diverse internal & external audiences including executive leadership
- Ability to thrive in a collaborative & fast-paced environment
- Results-oriented individuals with a strong work ethic & ability to complete projects with minimal oversight; track record of successful IND, CTA, NDA/BLA, & MAA submissions
- Knowledge of GxP, ICH, FDA, EMA & other global regulations & guidance
- Attention to detail & an ability to balance analytical & critical-thinking skills to develop data-driven, strategically oriented regulatory proposals & documents
- Strong experience leading regulatory CMC strategy & input for biologics development programs
- Bachelor's degree in a relevant scientific discipline; advanced degree (Master's or PhD) in relevant discipline preferred