Regulatory Publishing Specialist Global Compliance Projects

Position: Regulatory Publishing Specialist for Global Compliance Projects
Drive regulatory submission publishing for global markets as a dynamic 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 formats

• Compile and validate submissions for regulatory compliance

• Ensure accuracy and consistency across published materials

• Coordinate projects with stakeholders and manage timelines

• Conduct quality checks and address findings prior to submission

Requirements:

• Bachelor's in Life Sciences or related field

• 3+ years in Regulatory Affairs with eCTD experience

• International submission experience preferred

• Knowledge of eDMS and document preparation tools

• Strong attention to detail and organization

Leverage your skills in regulatory publishing to ensure high-quality submission management in a global, remote setting.
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