[Hiring] Regulatory Consultant @Syneos Health

Role Description

Regulatory Consultant (Veeva RIM) at Syneos Health® involves the following responsibilities:

• Create and Maintain Content Plans within Veeva Vault RIM
• Translating Smartsheet timelines into Microsoft Project and Veeva Vault RIM
• Assist with planning, managing, and tracking of 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 to explain difficult information, and attention to detail
• Submission Technology: Proficiency in electronic submission tools and software, such as eCTD and regulatory information management systems
• Project Management Technology: Experience and proficiency with project management tools and software

Qualifications

• B.S. (or equivalent experience) and 5+ years of Regulatory Affairs Work Experience, with a focus on publishing and/or submissions
• M.S. (or equivalent experience) and 3+ years of Regulatory Affairs Work Experience, with a focus on publishing and/or submissions
• In-depth understanding of regulatory requirements and guidelines including FDA regulations, EMA guidelines and ICH standards

Requirements

• Keywords: eCTD, NDA, IND, EU CTA, MAA, EU CTR, NDS
• Keywords: Insight Publisher, Lorenz Publisher, Veeva Vault RIM, Content Planning, eCTD Viewers, DXC (ISI) Toolbox
• Keywords: Smartsheet, Microsoft Project, Excel, Office timeline Pro

Benefits

• Passionate about developing our people through career development and progression
• Supportive and engaged line management
• Technical and therapeutic area training
• Peer recognition and total rewards program
• Commitment to building an inclusive culture
• Opportunity to shape solutions that impact lives

Company Description

Syneos Health has worked with:

• 94% of all Novel FDA Approved Drugs
• 95% of EMA Authorized Products
• Over 200 Studies across 73,000 Sites and 675,000+ Trial patients