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 & 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. xhqgsiq 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.
