Job opportunity
Principal Regulatory Publishing Lead
Jobgether
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 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.
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Apply on source site 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.
#J-18808-Ljbffr