Regulatory Consultant (Veeva RIM)
Skills
About the role
This is a remote Regulatory Consultant role in Ontario, Canada, focused on regulatory submission planning and coordination. You will maintain content plans in Veeva Vault RIM, translate submission timelines into project plans, and support regulatory managers with tracking and publishing activities. The role is intended for a regulatory-affairs professional with publishing or submissions experience in life sciences.
What you’ll do
- Create and maintain content plans in Veeva Vault RIM.
- Translate Smartsheet timelines into Microsoft Project and Veeva Vault RIM.
- Plan, manage, and track regulatory submissions.
- Support Vertex Global Submission Managers with project-management tasks.
- Coordinate communications and submissions with Vertex Publishing.
- Work to firm deadlines while adapting to changing priorities.
What they’re looking for
- A bachelor's degree or equivalent experience with at least five years of regulatory-affairs experience, or a master's degree or equivalent experience with at least three years.
- Experience focused on regulatory publishing and/or submissions.
- Knowledge of FDA regulations, EMA guidelines, and ICH standards.
- Proficiency with electronic submission tools and regulatory information-management systems.
- Strong organization, written and verbal communication, and attention to detail.
- Experience with project-management tools and software.
Nice to have
- Experience with Insight Publisher, Lorenz Publisher, DXC ISI Toolbox, or eCTD viewers.
- Experience with Smartsheet, Microsoft Project, Excel, or Office Timeline Pro.
- Experience with eCTD, NDA, IND, EU CTA, MAA, EU CTR, or NDS submissions.
What’s on offer
- Remote work from Ontario, Canada.
- The posting does not state a salary or benefits package.
Questions about this role
Is this Regulatory Consultant role remote?
Yes. It is listed as remote in Ontario, Canada.
How much regulatory experience is required?
The posting asks for five or more years with a bachelor's degree, or three or more years with a master's degree, focused on publishing or submissions.
Which regulatory systems are named?
The role uses Veeva Vault RIM and may involve Insight Publisher, Lorenz Publisher, DXC ISI Toolbox, and eCTD viewers.
Does the posting list a salary?
No salary is stated in the posting.
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