Director, Global Regulatory Strategy

Zura Bio, Inc

3d•$196,000 - $236,000

About The Position

Zura is a clinical‑stage biotechnology company advancing clinical development of novel therapeutic candidates for autoimmune and inflammatory diseases with significant unmet medical need. Our work is focused on understanding immune‑mediated disease and translating that science into carefully designed clinical programs, with patients and their challenges guiding our approach. Zura is building and advancing a growing portfolio of clinical programs informed by strong scientific expertise and disciplined execution. Across the organization, teams work closely together to progress development thoughtfully, with a shared emphasis on data quality, rigor, and integrity. At Zura, we operate as One Zura. This means collaborating across functions, valuing diverse perspectives, and taking shared ownership of our work—from problem‑solving to execution. Joining Zura 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. We are seeking a highly motivated and experienced Director, Global Regulatory Strategy to join our dynamic team at Zura, a growing biotech company. The ideal candidate will be collaborative, science-driven, and passionate about working on innovative investigational products. The Director, Global Regulatory Strategy will be the strategic regulatory driver for one or more monoclonal antibody (mAb) and biologic-device combination product development programs. This role will be accountable for creating and executing innovative global regulatory strategies that support efficient clinical development and global commercialization. As Director, Global Regulatory Strategy, you will develop and lead health authority interactions — including End-of-Phase 2 (EOP2) FDA meetings, EMA Scientific Advice, and other critical agency engagements to align development plans and facilitate approvals. Additionally, you will oversee the preparation and submission of high-quality global regulatory submissions, including INDs, CTAs, and amendments, ensuring compliance with regional and global requirements.

Requirements

Minimum of 10 years’ experience in the pharmaceutical/biotech industry, with a minimum of 8 years’ experience in drug/biologic regulatory affairs.
Proven track record of leading global regulatory strategy for complex development programs from early- to late-stage development.
Demonstrated experience leading and/or supporting major health authority interactions (e.g., FDA EoP2).
Experience shaping the regulatory strategy and design of pivotal clinical studies.
In-depth understanding of global regulatory requirements for biologics, 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.
Proven ability to lead and motivate teams toward achieving joint objectives and business goals.
Proven ability to influence decision-making by cross-functional teams, senior leadership, and governance committees.
Excellent organizational and program management skills that ensure timely completion of objectives by appropriate prioritization, scheduling and assignment of tasks.

Nice To Haves

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.
Experience supporting regulatory inspections and Phase 3 readiness activities is preferred.

Responsibilities

Lead the development and execution of regulatory strategies for assigned programs, ensuring alignment with senior leadership, development goals, and worldwide regulatory requirements to drive product development.
Lead the strategy, preparation, and execution of major global health authority interactions, including FDA End-of-Phase 2 meetings, EMA Scientific Advice, and other milestone regulatory discussions, and serve as the primary health authority contact for assigned programs.
Own planning, coordination, and execution of global regulatory submissions, including initial clinical trial applications (INDs, CTAs), subsequent amendments or substantial modifications, and notifications, and lead early planning for marketing applications (BLA/MAA).
Anticipate regulatory challenges, assess risks, and develop mitigation strategies to minimize impact to development timelines and approvals, escalating key risks to senior leadership with recommended options.
Lead and mentor members of the regulatory sub-team, fostering a culture of collaboration, accountability, and continuous learning. Represent Regulatory Affairs on program core teams, ensuring alignment across cross-functional departments.
Monitor and interpret evolving global regulatory policy, guidance, and precedent, translating insights into strategic recommendations for program teams and senior leadership.
Perform regulatory review of clinical and nonclinical documents, including investigator’s brochures, study protocols, clinical study reports, labeling, and application summaries.