Coordinator, Regulatory Operations - Remote

Overview

The Coordinator, Regulatory Operations will build and maintain relationships with internal and external contacts, manage submission files, and create compliant documents to support regulatory submissions.

In Short

• Maintain liaison with clients and internal teams.
• Download and upload client files using document transfer sites.
• Create e-compliant documents using Microsoft Office and Adobe tools.
• Prepare eCTD submissions and other regulatory documents.
• Quality check submissions and troubleshoot issues.
• Attend weekly department meetings and contribute to discussions.
• Manage time and projects effectively to meet deadlines.
• Maintain confidentiality and client information integrity.
• Support additional department services as required.
• Continuous professional development in regulatory knowledge.

Requirements

• B.Sc in Life Sciences or 3-5 years in Regulatory Operations.
• Excellent written and verbal communication skills.
• Proficiency with Microsoft Word and Adobe Acrobat.
• Experience with eCTD and NeeS submissions is an asset.
• Strong time management and organizational skills.
• Attention to detail and results-oriented mindset.
• Able to multitask and manage multiple projects.
• Positive attitude and team-oriented approach.
• Excellent conflict resolution skills.
• Ability to meet tight deadlines consistently.

Benefits

• Comprehensive medical, dental, and vision care.
• Support for working families including backup care and adoption assistance.
• Paid parental and caregiver leave.
• Training programs and professional development resources.
• Opportunities for mentorship and volunteer activities.