Regulatory Consultant – Submission Manager, Veeva RIM

🔥 0 minutes ago

🇷🇸 Serbia – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Syneos Health

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. They translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. By utilizing advanced technologies and insights, Syneos Health collaborates with clients to speed the delivery of important therapies to patients worldwide, offering services that span the entire clinical-to-commercial spectrum.

📋 Description

• 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)