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.
In this role, you will lead the planning and authoring of regulatory submission documents across Zura's portfolio. You will be responsible for regulatory medical writing strategy and timely deliverables for one or more projects or programs, including oversight when contractors/vendors are used for initial writing, and for authoring documents that support our global regulatory submissions (e.g., INDs/CTAs, NDAs/BLAs/MAAs, and health authority meeting packages). This role focuses on submission-level and health authority–facing documents and partners closely with Clinical Medical Writing, which owns study-level documents (e.g., protocols, clinical study reports, and investigator's brochures).
You will collaborate with cross-functional subject matter experts (SMEs) in Regulatory Affairs, Clinical Development, Clinical Medical Writing, Biostatistics, Drug Safety, Nonclinical, Clinical Pharmacology, Bioanalytical, and CMC to meet aggressive timelines. You will project manage high-quality regulatory documents from start to finish, develop strong relationships, and be an advocate for best practices in Regulatory Medical Writing. You will help grow the regulatory medical writing organization through Zura’s pipeline growth.
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…