Regulatory Consultant – Submission Manager, Veeva RIM
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Job Description
Regulatory Consultant managing Veeva Vault RIM submission plans and regulatory publishing for Syneos Health’s life sciences clients. Supporting Vertex submission managers with project tracking and coordination.
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 regulatory submissions
- Support Vertex Global Submission Managers with project management activities, tasks, and tracking
- Coordinate and communicate regulatory submissions to Vertex Publishing
- Work with firm deadlines and adapt to changing requirements and priorities
Requirements:
- 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 regulatory submissions
- Support Vertex Global Submission Managers with project management activities, tasks, 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, written/verbal communication, and attention to detail
- Proficiency in electronic submission tools and software, including eCTD and regulatory information management systems
- Experience with Insight Publisher, Lorenz Publisher, Veeva Vault RIM, Content Planning, eCTD Viewers, and DXC (ISI) Toolbox
- Experience and proficiency with project management tools and software, including Smartsheet, Microsoft Project, Excel, and Office Timeline Pro
- B.S. or equivalent experience and 5+ years of Regulatory Affairs work experience, focused on publishing and/or submissions; OR M.S. or equivalent experience and 3+ years of Regulatory Affairs work experience, focused on publishing and/or submissions
- In-depth understanding of regulatory requirements and guidelines, including FDA regulations, EMA guidelines, and ICH standards
- Knowledge of eCTD, NDA, IND, EU CTA, MAA, EU CTR, and NDS
Benefits:
- Career development and progression
- Supportive and engaged line management
- Technical and therapeutic area training
- Peer recognition
- Total rewards program
- Inclusive culture
- Remote work (Pre-Approved)
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