EY Manager - PM-PMO TD 

India, Karnataka, Bengaluru 

861255061

Key Responsibilities:

• Manage end-to-end IT projects focused on regulatory compliance and submission systems.
• Lead the implementation and optimization of regulatory platforms including Veeva Vault RIM , RIMS systems , and other document and submission lifecycle tools.
• Partner with Regulatory Affairs, Quality, and IT teams to align technology solutions with evolving compliance needs.
• Oversee data integrity, system validation, and audit readiness in compliance with GxP and 21 CFR Part 11 .
• Drive improvements in document management workflows for eCTD , CMC , and labeling submissions .
• Develop and manage project timelines, budgets, risks, and deliverables using standard methodologies (Agile, Waterfall, or hybrid).
• Ensure effective change management, training, and communication across stakeholder groups.
• Collaborate with vendors and technology partners to deliver scalable and compliant solutions.

Qualifications:

• Bachelor’s or Master’s degree in Computer Science, Life Sciences, Regulatory Affairs, or a related field.
• 10–15 years of IT project management experience within pharmaceutical regulatory operations.
• Strong knowledge of regulatory submission processes , including eCTD , CMC documentation , and labeling .
• Experience managing RIMS platforms and tools such as Veeva Vault RIM .
• Solid understanding of GxP , 21 CFR Part 11 , and validation requirements in a regulated environment.
• PMP, PRINCE2, or other relevant project management certification preferred.
• Excellent stakeholder engagement and communication skills.

Preferred Skills:

• Experience with data migration, system validation, or integration projects in a regulatory context.
• Familiarity with global regulatory requirements (FDA, EMA, etc.).
• Knowledge of digital submission standards and structured content authoring tools.

EY exists to build a better working world, helping to create long-term value for clients, people and society and build trust in the capital markets.