Regulatory Consultant, Veeva RIM

This is a fully remote position, open to applicants in Canada.

📋 Description

• Develop and uphold content plans utilizing Veeva Vault RIM.

• Convert Smartsheet timelines into Microsoft Project and Veeva Vault RIM.

• Aid in the planning, management, and tracking of regulatory submissions.

• Provide support to Vertex Global Submission Managers with project management tasks and tracking.

• Facilitate the coordination and communication of regulatory submissions to Vertex Publishing.

• Operate under strict deadlines and swiftly adjust to evolving requirements and priorities.

⛳️ Requirements

• Develop and uphold content plans utilizing Veeva Vault RIM.

• Convert Smartsheet timelines into Microsoft Project and Veeva Vault RIM.

• Aid in the planning, management, and tracking of regulatory submissions.

• Experience in supporting project management activities, tasks, and tracking.

• Capability to coordinate and communicate regulatory submissions to Vertex Publishing.

• Ability to operate under strict deadlines and quickly adapt to changing requirements and priorities.

• Exceptional organization, written and verbal communication skills, and attention to detail.

• Proficient in electronic submission tools and software, including eCTD and regulatory information management systems.

• Familiarity with Insight Publisher, Lorenz Publisher, Veeva Vault RIM, Content Planning, eCTD Viewers, and DXC (ISI) Toolbox.

• Experience and expertise in project management tools and software.

• Knowledge of Smartsheet, Microsoft Project, Excel, and Office timeline Pro.

• B.S. (or equivalent experience) with over 5 years of experience in Regulatory Affairs, concentrated on publishing and/or submissions; or M.S. (or equivalent experience) with over 3 years of experience in Regulatory Affairs, focused on publishing and/or submissions.

• Comprehensive understanding of FDA regulations, EMA guidelines, and ICH standards.

• Familiarity with eCTD, NDA, IND, EU CTA, MAA, EU CTR, and NDS.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and involved line management.

• Training in technical and therapeutic areas.

• Recognition from peers.

• Comprehensive total rewards program.

• Inclusive workplace culture.

• Reasonable accommodations, when appropriate, for employees or applicants with disabilities.