07 Sep
|
ProductLife Group
|
Montreal
07 Sep
ProductLife Group
Montreal
Drive regulatory submission publishing for global markets as a agile Publishing Specialist. Focus on eCTD and various formats to ensure compliance and quality in submissions.In this role, you will support global regulatory submission activities, compiling and validating documents across regions like the EU, US, and more. With a Bachelor's in Life Sciences and over 3 years in Regulatory Affairs, your expertise in eCTD publishing will shine. You'll work closely with internal teams to manage multiple projects, ensuring every submission meets stringent health authority standards.Key Responsibilities:Perform publishing in eCTD, NeeS, ePaper,
and ACTD formatsCompile and validate submissions for regulatory complianceEnsure accuracy and consistency across published materialsCoordinate projects with stakeholders and manage timelinesConduct quality checks and address findings prior to submissionRequirements:Bachelor's in Life Sciences or related field3+ years in Regulatory Affairs with eCTD experienceInternational submission experience preferredKnowledge of eDMS and document preparation toolsStrong attention to detail and organizationLeverage your skills in regulatory publishing to ensure high-quality submission management in a global, remote setting.
📌 Regulatory Publishing Specialist For Global Compliance Projects (Montreal)
🏢 ProductLife Group
📍 Montreal