Regulatory Medical Writing Director — Submissions Leader

Regulatory Jobs; United States; Remote; USD 208,000 - 238,000; Full time

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 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