Regulatory Operations Manager

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Requirements:

• Bachelor's degree in life sciences, information technology, or business.
• 6+ years of experience in pharmaceutical Regulatory Operations or similar discipline.
• Hands-on experience publishing original applications and maintenance submissions for various regulatory applications.
• Proficient knowledge of electronic publishing tools for regulatory submissions.
• Expert knowledge of eCTD submission requirements and lifecycle management concepts.
• Strong project management, communication, and interpersonal skills.
• Ability to work independently and troubleshoot system errors.

Responsibilities:

• Publish high-quality electronic regulatory submissions for global health authorities.
• Manage and triage workload for large/complex submissions.
• Perform quality control checks on formatted documents prior to submission.
• Provide training on document templates and style guides.
• Identify and resolve document formatting and publishing issues.
• Monitor changes to submission guidance and update processes.
• Assist with development of new department SOPs.