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.You could be just the right applicant for this job Read all associated information and make sure to apply.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 & ExecutionLead 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 objectivesHealth Authority InteractionsLead 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 meetingsServe as the primary regulatory lead and company spokesperson in agency engagementsOversee development of high-quality briefing materials, ensuring clear positioning and alignment with regulatory strategyRegulatory Problem Solving & InnovationProvide expert leadership in navigating complex and ambiguous regulatory landscapesDevelop creative, data-driven solutions to mitigate regulatory risks and barriersLeverage regulatory intelligence and competitive insights to inform strategyLabeling Strategy & GovernanceLead the global labeling strategy and workstream, including:Development of target product profile (TPP) and core labeling positionsOversight of labeling negotiations with health authoritiesRisk Management & Strategic CommunicationIdentify, assess, and proactively communicate regulatory risks and opportunitiesDevelop and maintain regulatory risk mitigation plansTrade-off analysesScenario planning and decision frameworksThis 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 programDemonstrated success leading major health authority interactions (e.g., FDA End-of-Phase 2, pre-NDA/BLA, and EMA scientific advice) and influencing regulatory outcomesProven ability to solve complex regulatory challenges with innovative and strategic approachesExtensive experience shaping pivotal clinical study design and registration-enabling data packages in partnership with Clinical Development and BiostatisticsDirect experience leading major regulatory submissions (IND/CTA, BLA/NDA and/or MAA), including submission planning and responses to health authority information requestsStrong experience in labeling strategy and negotiationsIn-depth understanding of global regulatory requirements for biologics (FDA, EMA, MHRA, and PMDA), including ICH guidelines, GCP, and region-specific regulatory frameworksStrong verbal and written communication skills, with the ability to clearly articulate regulatory strategies and risksAbility to thrive in a dynamic, fast-paced environment, and manage multiple priorities across different time zones and culturesLeadership: Proven ability to lead and motivate teams toward achieving joint objectives and business goalsPreferred 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 preferredExperience in rare disease drug development, innovative trial design, and expedited regulatory pathways is highly desiredThis 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.

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