Global Regulatory Publishing Lead (eCTD Expert)

ProductLife Group; United States; On-site; USD 100,000 - 130,000; Full time

Job summary

A leading regulatory consulting firm in the United States seeks a Regulatory Publishing Expert/Lead. The ideal candidate will ensure compliant and high-quality electronic submissions across global health authorities. Responsibilities include end-to-end publishing for submissions, operational ownership of platforms, maintaining validated systems, and people leadership. Candidates should possess 8–10+ years of experience in regulatory publishing and a Bachelor's degree in Life Sciences. This role involves cross-functional collaboration and quality oversight in a fast-paced environment.

Qualifications

• 8–10+ years of hands-on regulatory publishing experience in pharma/biotech or consulting.
• Deep familiarity with eCTD standards and regulatory guidance.

Responsibilities

• End-to-end eCTD/electronic submission publishing for initial and life-cycle submissions.
• Operational ownership of publishing platforms including version upgrades.
• Quality oversight with enforcement of GxP and publishing best practices.

Skills

Regulatory publishing experience

Cross-functional collaboration

Quality oversight

People leadership

Business development support

Education

Bachelor’s degree in Life Sciences

Advanced degree

Tools

Lorenz DocuBridge

EXTEDO

Microsoft Word

Microsoft Excel

Adobe Acrobat Pro

Job description

A leading regulatory consulting firm in the United States seeks a Regulatory Publishing Expert/Lead. The ideal candidate will ensure compliant and high-quality electronic submissions across global health authorities. Responsibilities include end-to-end publishing for submissions, operational ownership of platforms, maintaining validated systems, and people leadership. Candidates should possess 8–10+ years of experience in regulatory publishing and a Bachelor's degree in Life Sciences. This role involves cross-functional collaboration and quality oversight in a fast-paced environment.