Senior or Executive Director, Global Regulatory Strategy

Job Description

The Senior or Executive Director, Global Regulatory Strategy is a key leadership role responsible for defining and executing global regulatory strategies across development programs in a fast-paced, clinical-stage biotech environment.

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This individual serves as the primary architect of regulatory pathways, leads high-stakes health authority interactions, and drives proactive, innovative solutions to complex regulatory challenges to accelerate development and approval timelines. This role partners cross-functionally to ensure aligned, data-driven strategies that balance speed, compliance, and long-term lifecycle success.

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Deliverables:

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Global Regulatory Strategy & Execution

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• Lead the development and implementation of integrated global regulatory strategies across all stages of development (pre-IND through registration and lifecycle management)
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• Drive forward-looking regulatory planning, including identification of accelerated/expedited pathways (e.g., Fast Track, Breakthrough Therapy, PRIME, etc.)
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• Ensure alignment of regulatory strategy with clinical, CMC, and commercial objectives
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Health Authority Interactions

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• Lead strategy, preparation, and execution of key regulatory agency interactions (FDA, EMA, and other global agencies), including:
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• Pre-IND, End-of-Phase 2, pre-NDA/BLA, scientific advice, and ad hoc meetings
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• Serve as the primary regulatory lead and company spokesperson in agency engagements
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• Oversee development of high-quality briefing materials, ensuring clear positioning and alignment with regulatory strategy
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Regulatory Problem Solving & Innovation

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• Provide expert leadership in navigating complex and ambiguous regulatory landscapes
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• Develop creative, data-driven solutions to mitigate regulatory risks and barriers
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• Leverage regulatory intelligence and competitive insights to inform strategy
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Labeling Strategy & Governance

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• Lead the global labeling strategy and workstream, including:
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• Development of target product profile (TPP) and core labeling positions
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• Oversight of labeling negotiations with health authorities
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Risk Management & Strategic Communication

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• Identify, assess, and proactively communicate regulatory risks and opportunities
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• Develop and maintain regulatory risk mitigation plans
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• Trade-off analyses
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• Scenario planning and decision frameworks
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This is a remote role operating from the US, candidates must be generally available during EST operating hours.

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Profile:

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Required Qualifications:

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• 15+ years of experience in drug/biologic regulatory affairs, including prior accountability as global or US regulatory strategy lead for a development program
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• Demonstrated success leading major health authority interactions (e.g., FDA End-of-Phase 2, pre-NDA/BLA, and EMA scientific advice) and influencing regulatory outcomes
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• Proven ability to solve complex regulatory challenges with innovative and strategic approaches
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• Extensive experience shaping pivotal clinical study design and registration-enabling data packages in partnership with Clinical Development and Biostatistics
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• Direct experience leading major regulatory submissions (IND/CTA, BLA/NDA and/or MAA), including submission planning and responses to health authority information requests
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• Strong experience in labeling strategy and negotiations
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• In-depth understanding of global regulatory requirements for biologics (FDA, EMA, MHRA, and PMDA), including ICH guidelines, GCP, and region-specific regulatory frameworks
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• Strong verbal and written communication skills, with the ability to clearly articulate regulatory strategies and risks
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• Ability to thrive in a dynamic, fast-paced environment, and manage multiple priorities across different time zones and cultures
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• Leadership: Proven ability to lead and motivate teams toward achieving joint objectives and business goals
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Preferred Qualifications:

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• Experience as lead regulatory product strategist in one or more major regions in addition to the US (e.g., EU or Japan)
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• Experience with monoclonal antibodies & biologic-device combination products strongly preferred
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• Experience in rare disease drug development, innovative trial design, and expedited regulatory pathways is highly desired
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This is a highly exciting time to join a clinical‑stage biotech advancing clinical development of novel therapeutic candidates for autoimmune and inflammatory diseases with significant unmet medical need, who are building and advancing a growing portfolio of clinical programs informed by strong scientific expertise and disciplined execution.

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The organisation work as a unit, collaborating across functions, valuing diverse perspectives, and taking shared ownership of our work—from problem‑solving to execution. Joining means contributing to patient‑focused clinical development in a hands‑on environment where individual effort matters, collaboration is expected, and people are encouraged to grow while working toward a common goal.

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