Remote Regulatory Submissions Lead – Veeva RIM

Emploive

Canada

Hybrid

CAD 90,000 - 130,000

Full time

14 days+
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Job summary

Syneos Health Canada is seeking a Regulatory Consultant (Veeva RIM) to coordinate regulatory submissions and content planning within Veeva Vault RIM. The role supports submission managers with project tracking and timely delivery under firm deadlines.

Ideal candidates hold a B.S. or M.S. in regulatory affairs with 3+ to 5+ years of experience, and are proficient with Smartsheet, MS Project, and eCTD tools to ensure compliant submissions across regulatory bodies.

Qualifications

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

Responsibilities

  • Create and Maintain Content Plans within Veeva Vault RIM.
  • Translating Smartsheet timelines into Microsoft Project and Veeva Vault RIM.
  • Assist with planning, managing, and tracking of regulatory submissions.
  • Support Vertex Global Submission Managers with project management activities and tracking.
  • Assist with coordination and communication of regulatory submissions to Vertex Publishing.
  • Ability to work with firm deadlines and adapt quickly to changing requirements and priorities.
  • Excellent organization and written/verbal communication to explain difficult information.

Skills

Regulatory submissions
Project management
Attention to detail
Written/verbal communication

Education

B.S. (or equivalent) with 5+ years of Regulatory Affairs
M.S. (or equivalent) with 3+ years of Regulatory Affairs

Tools

Veeva Vault RIM
Smartsheet
Microsoft Project
Excel
Office Timeline Pro
eCTD Viewers

Job description

Syneos Health Canada is seeking a Regulatory Consultant (Veeva RIM) to coordinate regulatory submissions and content planning within Veeva Vault RIM. The role supports submission managers with project tracking and timely delivery under firm deadlines.

Ideal candidates hold a B.S. or M.S. in regulatory affairs with 3+ to 5+ years of experience, and are proficient with Smartsheet, MS Project, and eCTD tools to ensure compliant submissions across regulatory bodies.

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