Director, Regulatory Medical Writing

Regulatory Toolkit

United States

Remote

USD 208,000 - 238,000

Full time

14 days+

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Benefits offered by this job

Medical Plans

Dental Plans

Vision Plans

Equity Compensation

Performance-Based Bonus

401(k) with Company Match

Paid Time Off

Parental Leave

Job summary

Zura is seeking a Director of Regulatory Medical Writing to lead the planning and authoring of regulatory submission documents for our portfolio. You will oversee strategy, timelines, and when vendors are engaged, ensuring high-quality, inspection-ready deliverables across us/cross-border programs.

You will collaborate with Regulatory Affairs, Clinical Development, Biostatistics, and other teams to align messaging with regulatory strategy and global guidelines, mentoring junior writers and

Qualifications

10+ years as a medical writer for regulated documents in pharma/biotech.
5+ years leading regulatory submission writing and health authority interactions.
Experience with CTD/Module 2, briefing documents, labeling, ISS/ISE.

Responsibilities

Lead planning and authoring of regulatory submissions (INDs/CTAs, NDAs/BLAs/MAAs).
Oversee writing when vendors operate and ensure timely deliverables.
Collaborate with SMEs across regulatory, clinical and CMC teams.
Manage review cycles, QC, and alignment with regulatory strategy.

Skills

Regulatory writing leadership

Team leadership

Project management

Regulatory strategy

Writing and editing

Communication

Mentoring junior writers

Vendor management

Regulatory guidelines (FDA/EMA/ICH)

AI-assisted writing

Education

Bachelor’s Degree in a relevant field

Tools

Microsoft Word

eCTD submission tools

AI writing tools

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.

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 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: