Director, Regulatory Medical Writing — Biotech Impact

Zura Bio Limited (Nasdaq: ZURA); United States; On-site; USD 208,000 - 238,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

Equity Compensation

Bonus Program

401(k) Match

PTO and Holidays

Parental Leave

Job summary

Zura Bio Limited seeks a Director of Regulatory Medical Writing to lead regulatory documentation across US and international programs. You will guide strategy, author major submissions, and manage external writers in a fast-paced biotech setting.

You will collaborate with Regulatory Affairs, Clinical Development, Biostatistics, and other teams to ensure inspection-ready deliverables, maintain AMA style, and drive on-time submissions for biologics programs.

Qualifications

• Ten+ years as a medical writer in pharma/biotech
• Lead writer for major regulatory submissions (CTD modules, ISS/ISE)
• Experience with US/intl submissions (FDA/EMA/PMDA, ICH guidelines)
• Experience preparing eCTD submissions with Regulatory Operations
• Experience writing for biologics (monoclonal antibodies)
• Strong data interpretation and ability to prepare data tables/figures
• Proficient in AMA style guidelines
• Excellent attention to detail and time management
• Clear written and verbal communication across functions
• Experience using AI software or managing vendors

Responsibilities

• Lead, write, and manage regulatory documents (CTD Module 2, ISS/ISE)
• Prioritize and track timelines for multiple submissions with PM
• Serve as Regulatory Medical Writing lead on project teams
• Develop program-level submission strategy and plans
• Maintain expert knowledge of FDA/EMA/PMDA/ICH guidelines
• Coordinate with Regulatory Affairs, Clinical Development, Biostatistics
• Lead responses and briefing documents for health authorities
• Oversee contract writers and vendors for quality and timeliness

Skills

Medical writing

Regulatory submissions

Leadership

Vendor management

AMA style

MS Word mastery

Biologics knowledge

Data interpretation

Cross-functional collaboration

AI tooling experience

Education

Bachelor's degree

Advanced degree in science/clinical field

Job description

Zura Bio Limited seeks a Director of Regulatory Medical Writing to lead regulatory documentation across US and international programs. You will guide strategy, author major submissions, and manage external writers in a fast-paced biotech setting.

You will collaborate with Regulatory Affairs, Clinical Development, Biostatistics, and other teams to ensure inspection-ready deliverables, maintain AMA style, and drive on-time submissions for biologics programs.