Principal Regulatory Publishing Lead

Lead complex regulatory publishing projects from Canada with advanced eCTD software and rigorous document quality control. Work remotely within a global clinical research environment.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 completionFinalise, format, quality-control, and publish electronic submissionsCoordinate multidisciplinary teams to ensure submission readinessManage complex regulatory dossiers and submission amendmentsSupport FDA, EMA, and post-marketing regulatory submissionsRequirements:
Bachelor's degree, preferably in a scientific disciplineAt least eight years of relevant regulatory publishing experienceAdvanced Adobe Acrobat, ISIToolbox, and regulatory software proficiencyStrong Microsoft Word styles, templates, and EndNote familiarityExcellent English communication, leadership, and problem-solving skillsApply regulatory publishing expertise, eCTD knowledge, and cross-functional leadership to support compliant global clinical submissions.
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