Lead complex regulatory publishing projects from Canada with advanced eCTD software and rigorous document quality control. Work remotely within a global clinical research workplace.

As Principal Regulatory Operations Publisher, you will independently prepare and finalise electronic regulatory submissions. You will coordinate with Medical Writing, Biostatistics, Programming, and Regulatory Affairs teams. The role also includes technical guidance, mentoring, and expert support for publishing challenges across oncology and rare disease programmes.

Key Responsibilities

Lead regulatory publishing projects from planning through completion

Finalise, format, quality-control, and publish electronic submissions

Coordinate multidisciplinary teams to ensure submission readiness





Manage complex regulatory dossiers and submission amendments

Support FDA, EMA, and post-marketing regulatory submissions

Requirements

Bachelor's degree, preferably in a scientific discipline

At least eight years of relevant regulatory publishing experience

Advanced Adobe Acrobat, ISIToolbox, and regulatory software proficiency

Strong Microsoft Word styles, templates, and EndNote familiarity

Excellent English communication, leadership, and problem-solving skills

Apply regulatory publishing expertise, eCTD knowledge, and cross-functional leadership to support compliant global clinical submissions.

📌 Principal Regulatory Publishing Lead (Winnipeg)
🏢 Jobgether
📍 Winnipeg