Regulatory Consultant – Submission Manager, Veeva RIM

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

📋 Description

• Develop and sustain content plans using Veeva Vault RIM.

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

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

• Assist Vertex Global Submission Managers with project management tasks and tracking.

• Organize and communicate regulatory submissions to Vertex Publishing.

• Work under strict deadlines while adapting to evolving requirements and priorities.

⛳️ Requirements

• Develop and sustain content plans using Veeva Vault RIM.

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

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

• Assist Vertex Global Submission Managers with project management tasks and tracking.

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

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

• Exceptional organizational skills, along with written and verbal communication abilities, and a keen attention to detail.

• Proficiency in electronic submission tools and software, such as eCTD and regulatory information management systems.

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

• Proficient in project management tools and software, including Smartsheet, Microsoft Project, Excel, and Office Timeline Pro.

• B.S. or equivalent experience with 5+ years in Regulatory Affairs focused on publishing and/or submissions; OR M.S. or equivalent experience with 3+ years in Regulatory Affairs focused on publishing and/or submissions.

• Comprehensive understanding of regulatory requirements and guidelines, including 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 engaged line management.

• Technical and therapeutic area training.

• Peer recognition initiatives.

• Comprehensive total rewards program.

• An inclusive workplace culture.

• Remote work options (Pre-Approved).