Senior Director, Regulatory Affairs Strategy
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
:The Senior Director, Regulatory Affairs Strategy is a senior individual contributor and people leader responsible for shaping, influencing, and executing global regulatory strategies across one or more complex development programs. This role serves as a critical bridge between program-level execution and portfolio-level strategic alignment
.The Senior Director will provide deep regulatory expertise, lead health authority interactions, mentor regulatory leaders, and partner closely with cross-functional and Regulatory leadership to ensure consistent, high-quality regulatory strategies that support corporate objectives. The role requires strong strategic judgment, the ability to navigate ambiguity, and comfort operating in a fast-paced, evolving biotech environment
.
Key Responsibilities
:
Regulatory Strategy & Leaders
- hipLead the development and execution of innovative global regulatory strategies to expedite development, maximize probability of success, and mitigate regulatory risk across assigned progra
- ms.Serve as a core regulatory strategist for complex and/or high-priority programs, with accountability for overall regulatory direction and outcom
- es.Anticipate and proactively address regulatory challenges, translating external regulatory trends and guidance into actionable strategi
- es.Ensure alignment between program-level strategies and broader portfolio and corporate regulatory objectiv
es.
Health Authority Engage
- mentLead and/or play a prominent role in interactions with FDA and other global Health Authorities, including briefing document development, meeting preparation, negotiation strategy, and follow
- -up.Provide strategic oversight and guidance on responses to regulatory questions, information requests, and post-meeting commitme
nts.
Cross‑Functional Partne
- rshipAct as the primary regulatory partner on cross-functional development teams, influencing decision-making across R&D, Clinical, CMC, Quality, Pharmacovigilance, and Commercial functions as appropr
- iate.Clearly communicate regulatory risks, opportunities, and recommendations to senior management and key stakehol
- ders.Represent Regulatory Affairs Strategy on cross-functional governance forums and committees as ne
eded.
People Leadership & Ment
- orshipProvide direct or matrix leadership to Regulatory Strategy personnel (e.g., Managers, Associate Directors, Directors), including coaching, mentoring, and development of future regulatory le
- aders.Support performance management, talent assessment, and succession planning in partnership with Regulatory leade
- rship.Foster a culture of accountability, collaboration, and continuous learning within the Regulatory Affairs organiz
ation.
Operational Excellence & Ov
- ersightOversee and contribute to the planning, preparation, and review of high-quality global regulatory submissions, including INDs, BLAs, MAAs, CTAs/IMPDs, amendments, annual reports, and briefing pa
- ckages.Ensure regulatory deliverables are strategically sound, internally aligned, and completed within established tim
- elines.Manage or oversee external consultants and vendors to ensure efficient execution and high-quality ou
tcomes.
Requi
- rements:Bachelor’s degree in a scientific discipline required; advanced degree (Master’s or PhD) strongly pr
- eferred.Minimum of 12–15+ years of regulatory experience in the biopharmaceutical industry, with demonstrated progression in scope and com
- plexity.Significant experience developing and executing global regulatory strategies for biologics across clinical development and, preferably, marketing appli
- cations.Demonstrated leadership in Health Authority interactions, including FDA and major ex‑US a
- gencies.Strong understanding of global regulatory requirements, guidance, and processes (FDA, EMA, ICH, and other key r
- egions).Experience leading or contributing to INDs and BLAs; MAA experience pr
- eferred.Proven ability to think strategically while remaining hands-on as
- needed.Excellent written and verbal communication skills, with the ability to influence senior leaders and cross-functional p
- artners.Experience mentoring and developing regulatory talent in a matrixed, fast-paced envi
- ronment.Comfort operating with ambiguity and shifting priorities in a high-growth biotech
setting.
Work Env
- ironment:Rem
- ote-basedDynamic, interactive, fast-paced, and entrepreneurial en
- vironmentDomestic or international travel are required
(10-20%)
Salary range f
or posting$270,000 - $2
90,000 USD
Compensation is based on a number of factors, including market location, and may vary depending on job-related knowledge, skills, and experience. Equity 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 pare
ntal leave.
