Publishing Specialist in Regulatory Affairs for International Markets

Become a key player as a Publishing Specialist focused on regulatory submissions. Your expertise will ensure compliance and quality in a global publishing environment utilizing eCTD and NeeS formats.

In this pivotal role, you will support the publishing of regulatory submissions across global markets, including the EU, US, and Canada. You will be responsible for compiling and validating submissions while ensuring they meet stringent quality standards. This position is perfect for someone looking for long-term visibility in a dynamic regulatory environment.

Key Responsibilities

• Manage publishing activities in eCTD and related formats
• Compile and validate international regulatory submissions
• Ensure compliance with regional health authority requirements
• Collaborate with stakeholders on project coordination
• Maintain submission documentation and version accuracy

Requirements

• Bachelor’s degree in Life Sciences or similar
• At least 3 years experience in Regulatory Affairs
• Hands-on eCTD publishing experience is a must
• Strong skills in electronic document management
• Proficient in Adobe Acrobat Pro for PDF editing

Contribute your regulatory expertise to enhance submission quality and compliance across various international markets.