Senior or Executive Director, Global Regulatory Strategy

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.

Deliverables:

Global Regulatory Strategy & Execution

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

Health Authority Interactions

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

Regulatory Problem Solving & Innovation

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

Labeling Strategy & Governance

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

Risk Management & Strategic Communication

• Identify, assess, and proactively communicate regulatory risks and opportunities
• Develop and maintain regulatory risk mitigation plans
• Trade-off analyses
• Scenario planning and decision frameworks

This is a remote role operating from the US, candidates must be generally available during EST operating hours.

Profile:

Required Qualifications:

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

Preferred Qualifications:

• Experience as lead regulatory product strategist in one or more major regions in addition to the US (e.g., EU or Japan)
• Experience with monoclonal antibodies & biologic-device combination products strongly preferred
• Experience in rare disease drug development, innovative trial design, and expedited regulatory pathways is highly desired

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.

The organisation work as a unit, collaborating across functions, valuing diverse perspectives, and taking shared ownership of our work—from problem-solving to execution. xhyhwjd 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.