Documentation Specialist

Responsibilities

• Organize, maintain, and manage electronic regulatory documents including applications, submissions, dossiers, and correspondence, on shared directories and other electronic platform,
• Support regulatory project leaders to prepare administrative M1 documents for various typeds of Health Canada regulatory submissions (NDS, SNDS, Response to Clarifaxes etc.) efficiently and accurately in accordance with current Health Canada Guidelines and Corporate Guidance.
• Overview and maintain regulatory shared mailbox by facilitating effective communication and coordinating correspondence to internal stakeholders.
• Maintain accurate records of regulatory documents and submissions by upload regulatory dossiers and supportive information into corporate internal database and platform.
• Act as a backup to the regulatory Regulatory Coordinator to provide operational support as needed.
• Collaborate with regulatory affairs professionals, subject matter experts, and cross-functional local and global teams to gather necessary documentation and information for regulatory submissions and pharmacovigilance related safety reports.
• Participate in any ad-hoc or special regulatory projects as needed.