Regulatory Submissions Coordinator, Veeva RIM & MS Projects

Syneos Health Canada Inc.; Canada; Remote; CAD 70,000 - 95,000; Full time

Job summary

Syneos Health Canada Inc. is seeking a Reg Submission Coordinator to manage and coordinate regulatory submissions using Veeva Vault RIM and MS Project.

You will translate timelines, maintain content plans, and support global submission managers to ensure timely, accurate submissions. Candidates should have a strong regulatory publishing background, experience with FDA/EMA guidelines, and excellent communication skills.

Qualifications

• B.S. (or equivalent) with 5+ years of Regulatory Affairs work experience focusing on publishing and/or submissions.
• M.S. (or equivalent) with 3+ years of Regulatory Affairs work experience focusing on publishing and/or submissions.
• In-depth understanding of regulatory requirements and guidelines including FDA regulations, EMA guidelines and ICH standards.

Responsibilities

• Create and Maintain Content Plans within Veeva Vault RIM.
• Translate Smartsheet timelines into Microsoft Project and Veeva Vault RIM.
• Assist with planning, managing, and tracking of regulatory submissions.
• Support Global Submission Managers with project management activities, tasks and tracking.
• Assist with coordination and communication of regulatory submissions to Publishing.
• Ability to work with firm deadlines and adapt quickly to changing requirements and priorities.
• Excellent organization, written/verbal communication to explain difficult information, and attention to detail.
• Submission Technology: Proficiency in electronic submission tools and software, such as eCTD and regulatory information management systems.

Skills

Veeva Vault RIM

Project management

Regulatory submissions

Content planning

Communication

Education

B.S./BSc in related field

M.S. in related field

Tools

Veeva Vault RIM

Smartsheet

Microsoft Project

Excel

Office Timeline

Job description

Syneos Health Canada Inc. is seeking a Reg Submission Coordinator to manage and coordinate regulatory submissions using Veeva Vault RIM and MS Project.

You will translate timelines, maintain content plans, and support global submission managers to ensure timely, accurate submissions. Candidates should have a strong regulatory publishing background, experience with FDA/EMA guidelines, and excellent communication skills.