Director, Regulatory Medical Writing

Zura Bio Limited (Nasdaq: ZURA)

United States

On-site

USD 208,000 - 238,000

Full time

7 days ago

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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 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’ll Do

We are seeking a highly motivated and experienced Director of Regulatory Medical Writing to join our dynamic team at Zura, a growing biotech company.

Responsibilities

Collaborate with internal teams to lead, write, and manage complex regulatory documents (e.g., CTD Module 2 clinical overviews and summaries, integrated summaries of safety and efficacy, integrated summaries of immunogenicity, health authority briefing documents, pediatric plans [iPSPs/PIPs], and responses to health authority questions).
Ability to prioritize accordingly and track timelines/deliverables for multiple regulatory submissions and programs in collaboration with project management.
Serve as Regulatory Medical Writing lead on multiple project/core teams.
Develop and own program-level submission document strategy and integrated document plans, ensuring on-time, inspection-ready deliverables.
Function as subject matter expert within the department for assigned therapeutic/product areas.
Lead complex scientific key messaging/storyboarding cross-functional meetings, ensuring the messages are clear and consistent within and across documents.
Independently assimilate and interpret complex data and source documents to shape submission messaging.
Ensure compliance with appropriate conventions, proper grammar usage, and correct format requirements, as needed (e.g., formatting, hyperlinking).
Manage review cycles for documents; schedule and lead data interpretation meetings, comment resolution meetings, and other document-related meetings.
Establish and oversee QC processes for regulatory documents, performing QC reviews as needed.
Maintain expert knowledge of US and international regulations, requirements, and guidance associated with the preparation of regulatory submission documentation (e.g., ICH M4/CTD, eCTD, and regional FDA, EMA, and PMDA guidance).
Partner with Regulatory Affairs, Clinical Development, Biostatistics, Clinical Pharmacology, Bioanalytical, and Nonclinical teams to ensure regulatory document content and messaging align with overall regulatory strategy and submission timelines.
Lead the authoring of responses and briefing documents requested by health authorities (e.g., information requests, clinical holds, advisory committee briefing documents), and contribute content, data interpretation, and messaging to support those responses requested by regulatory agencies.
Select, oversee, and govern contract regulatory medical writers, FSP partners, and vendors, ensuring high-quality deliverables and on-time performance.

Required Qualifications

10+ years of direct experience as a medical writer preparing regulated documents in the pharmaceutical or biotechnology industry, including at least 5 years leading regulatory submission writing (e.g., marketing applications or major health authority interactions).
Experience as lead writer of key regulatory documents supporting major US and/or international regulatory submissions, comprising, but not limited to, CTD Module 2 summaries (2.4/2.5/2.6/2.7), briefing documents for health authority meetings, labeling documents (e.g., USPI, SmPC), and integrated summaries of safety and efficacy (ISS/ISE).
Experience working within or across compounds to ensure consistency of standards and messaging.
Ability to independently write and complete documents to completion.
Extensive working knowledge of relevant FDA, EMA, PMDA, and ICH guidelines for regulatory submission documentation, particularly ICH M4 (Common Technical Document) and eCTD requirements, with working knowledge of ICH E3
Experience in preparing and compiling documents for eCTD submission, working closely with Regulatory Operations.
Experience writing submission documents for biologic products (e.g., monoclonal antibodies or other therapeutic proteins), including integrated immunogenicity assessments, with working knowledge of FDA and EMA immunogenicity guidance for therapeutic proteins.
Deep understanding of the drug development process, including biologic development and the BLA pathway.
Strong ability to assimilate and analytically interpret scientific data. Experience preparing data tables and basic figures required.
Proficient knowledge of American Medical Association (AMA) style guidelines.
Advanced abilities to find and correct errors in spelling, punctuation, grammar, consistency, clarity, and accuracy.
Excellent attention to detail and time-management skills. Ability to balance multiple projects simultaneously.
Ability to create and follow style guides, lexicons, and document templates.
Excellent written and oral communication skills with an ability to clearly present technical information within and across functional areas.
Demonstrated high-level of proficiency in Microsoft Word.
Energetic, self‑motivated, and a hands‑on professional with a strong work ethic.
Ability to work collaboratively in a dynamic environment.
Strong desire and ability to be a team player, working and leading towards common goals.
Experience using AI software or managing vendors with this ability

Preferred Qualifications

Previous experience mentoring junior writers a plus.
Experience working with Accenture Starting Point templates and add‑on toolbars is a plus.
Experience supporting regulatory inspections and Phase 3 readiness activities is preferred.

Education