Business Analyst with Regulatory Exp

Title: Business Analyst with Regulatory Exp. Location: NY/PA/NY locations (Will be remote with opportunity to go onsite) Must be in the Tri State area. Duration: 6+ Months contract

• 5+ years of Regulatory Operations and Regulatory Information Management experience.
• Knowledge of drug development and approval process.
• Strong understanding of global R&D submission process and requirements including eCTD publishing principles and various application types (IND/CTA, NDA, MAA, NDS etc.)
• Knowledge of Global Regulatory guidelines and Processes (US / EU / APAC / etc.)
• Demonstrated Consulting experience, preferred.
• Experience working with applications for projects and regulatory activities (e.g., Insight, Veeva, Documentum, SharePoint, etc.).
• Knowledge of Regulatory (eDMS, Archive and RIM) systems including cross-functional usage requirements, business administration and best practices.
• Experience in gathering and documenting requirements, Business Process Analysis, Change Management Concepts, Current/Future State Analysis.
• Delivery experience
• Client engagement and relationship building skills.
• Conceptual thinking as well as analytical and problem-solving skills
• Strong communication skills, both verbal and written, at all levels
• Strong analytical skills
• Business development experience a plus
• Demonstrated ability to effectively collaborate with cross-functional virtual teams.