New · posted Oct 15
Zura Bio · Biotechnology
Director, Global Regulatory Strategy
- Remote, US
- Remote
- Full-time
- Director
Open until filled
The role
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.
What you need
Required Qualifications
- 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.
- Leadership: 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.
Education
- Bachelor’s degree in a scientific discipline (pharmacy, biology, chemistry, pharmacology) or related subject. Advanced degree or certification, preferred.
Preferred Qualificationsnice to have
- 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.
What you'll do
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 global 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.
- Global Regulatory Strategy: 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.
- Health Authority Interactions: 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.
- Global Submission Leadership: 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).
- Risk Management: 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.
- Team Leadership: 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.
- Competitive and Regulatory Landscape Analysis: Monitor and interpret evolving global regulatory policy, guidance, and precedent, translating insights into strategic recommendations for program teams and senior leadership.
- Documentation and Review: Perform regulatory review of clinical and nonclinical documents, including investigator’s brochures, study protocols, clinical study reports, labeling, and application summaries.
Pay and benefits
$196,000 – $236,000 a year
Employer providedExpected Salary Range
$196,000 - $236,000 USD
Our current benefits offerings include
Medical, Dental, and Vision Plans
Life and Disability Insurance
Health Savings Account (HSA) and Flexible Spending Account (FSA)
Equity Compensation
Performance‑Based Bonus Program
401(k) Plan with Company Match
Paid Time Off and Company Holidays
Paid Parental Leave
Job intelligence
The context around this role
Live data · October 15, 2026
Salary intelligence
How the pay compares
This role's midpoint is 8% below the US median for Regulatory Affairs roles at this level.
This roleEmployer provided
Director roles in the US101 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $196,000 | — | $236,000 |
| All US (middle half) | $209,500 | $235,000 | $264,000 |
This role: Zura Bio's own published range. Comparisons: the base pay employers published on open Regulatory Affairs roles at the same level on Regulatory Jobs, October 15, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Regulatory Affairs
The general path across 290 open Regulatory Affairs roles on Regulatory Jobs, with the titles they carry most. Not Zura Bio's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 27 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership13
- Regulatory submissions10
- GMP and compliance3
- Documentation and SOPs2
- Investigations and CAPA2
- Quality systems and risk1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- ICHICH quality guidelines(official source, opens in a new tab)Q1 stability, Q2(R2) analytical validation, Q7, Q9 risk management, Q10 quality systems
- ICHICH E6 good clinical practice(official source, opens in a new tab)The international standard for the conduct of clinical trials
- FDAFDA IND(official source, opens in a new tab)Investigational New Drug applications
- FDAFDA BLA(official source, opens in a new tab)Biologics License Applications
Company hiring pulse
Zura Bio on Regulatory Jobs
- 2
- Open roles
- 2
- Distinct roles
- 1
- Locations
More roles at Zura Bio
- View role
Director, Regulatory Medical Writing
Remote, USDirectorBiotechnology$208K–$238K
Similar Regulatory Affairs roles elsewhere
- View role
Associate Director, Regulatory Affairs
argenxRemote, USDirectorBiotechnology$164K–$226K
- View role
Director, Regulatory Affairs
argenxRemote, USDirectorBiotechnology$212K–$292K
- View role
Senior Director, Regulatory Affairs
Summit TherapeuticsRemote, USDirectorBiotechnology$203K
- View role
Executive Director, Regulatory Affairs – Global Regulatory Leader
Summit TherapeuticsRemote, USDirectorBiotechnology$231K
Director, Global Regulatory Strategy at Zura Bio
Open until filled. $196K–$236K a year, employer provided.