At EY, you’ll have the chance to build a career as unique as you are, with the global scale, support, inclusive culture and technology to become the best version of you. Join us and build an exceptional experience for yourself, and a better working world for all.
Requirements
- Bachelor’s degree in computer science, Information Technology, or a related technical discipline.
- 8–12 years of hands-on experience in regulatory area with around 3-5 years of experience in Veeva Vault RIMS configuration and development
- Proven proficiency in configuring the Veeva Vault platform, including objects, fields, roles, workflows, lifecycles, and reporting tools.
- Familiarity with Veeva APIs, Vault Loader, and other integration tools for data migration and system interoperability.
- Experience working in Agile/Scrum environments, contributing to iterative development and continuous improvement.
- Solid understanding of GxP compliance, CSV/CSA methodologies, and 21 CFR Part 11 requirements in validated environments.
- Strong analytical and problem-solving abilities, with excellent communication, client interaction, and documentation skills.
- Must-Have Skills & Attributes: 8–12 years of hands-on experience in regulatory area with around 3-5 years of experience in Veeva Vault RIMS configuration and development, with deep expertise in Regulatory Affairs and Regulatory information management system.
- Familiarity with electronic submission standards (eCTD, NeeS) and data standards (IDMP, xEVMPD).
- Proven success in client-facing roles, managing stakeholder expectations and delivering tailored Vault solutions.
- Excellent communication, presentation, and stakeholder engagement skills.
- Experience in IT project management, including planning, execution, and validation strategy development.
- Strong analytical skills to troubleshoot application issues, perform impact assessments, and recommend scalable solutions.
- In-depth understanding of Registrations, Submissions, Submission Planning, Archive process within regulated environments.
- Thorough understanding of Regulatory Intelligence, Quality in Digital, submission management and archival, and document management processes within regulated environments.
- Proven ability to mentor and lead junior team members, fostering technical growth and collaboration.
- Experience in training and cross-skilling resources, enabling team agility and knowledge sharing.
- A collaborative mindset with a focus on teamwork, innovation, and continuous improvement.
- Veeva Associate Administrator Certification and/or equivalent platform credentials.
Benefits
- Support, coaching and feedback from some of the most engaging colleagues around
- Opportunities to develop new skills and progress your career
- The freedom and flexibility to handle your role in a way that’s right for you
