Senior Director, Regulatory Affairs Strategy
Senior Director, Regulatory Affairs Strategy at Immunovant — Remote
- Company: Immunovant
- Location: Remote
- Employment type: FULL_TIME
- Salary: USD 270000–290000 / year
- Posted: 2026-06-17
About this role
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.