Regulatory Compliance Business Analyst

Role & responsibilities

Qualifications:

• Bachelors degree in computer science, Information Technology, Life Sciences or a related field.
• •4–7 years of experience as a Business Analyst in IT projects within regulated environments.
• Hands-on experience with Veeva Vault applications (Clinical, RIM, Quality, Safety) with demonstrated expertise in related business processes and workflows
• 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

• Proven experience in requirements gathering and documentation using tools like JIRA, Confluence, ALM, Lucid, Visio, Mural, etc.
• Familiarity with Veeva Vault configuration concepts (objects, lifecycles, workflows, security roles).
• Strong understanding of GAMP 5 methodology, System Development Life Cycle (SDLC), and validation planning
• Proficiency in testing and validation tools such as qTest and ALM, with strong dashboarding and reporting capabilities.
• Ability to collaborate with cross-functional teams (QA, IT, Manufacturing, Labs, Safety, Regulatory)
• Experience in client-facing roles, managing expectations and delivering solutions
• Strong communication and presentation skills
• Experience in IT project management and validation planning
• Familiarity with change control, deviation handling, and CAPA processes
• Proven ability to mentor junior resources
• Experience in training and cross-skilling resources
• Strong teamwork and collaboration mindset
• Veeva Vault admin certification