Job Description

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Job Title: Regulatory Affairs Specialist with Data Analysis, Veeva, RIM, ERP, and Business Process Experience

Location: Foster City, CA

Job Description:

We are seeking an experienced Regulatory Affairs Specialist with a strong background in data analysis, Veeva Vault, Regulatory Information Management (RIM), ERP systems, and business process optimization. The ideal candidate will support regulatory compliance, streamline business processes, and manage regulatory data within the pharmaceutical or life sciences industry.

Key Responsibilities:

Regulatory Affairs Management:

• Oversee regulatory submissions, approvals, and compliance activities, ensuring adherence to industry regulations and standards.
• Manage and maintain regulatory documentation and records within Veeva Vault and RIM systems.
• Collaborate with cross-functional teams to ensure alignment between regulatory strategies and business objectives.

Data Analysis and Reporting:

• Analyze regulatory data within Veeva Vault, RIM, and ERP systems to identify trends, patterns, and opportunities for improvement.
• Create and maintain dashboards, reports, and visualizations to support regulatory decision-making and process optimization.
• Monitor and report on key performance indicators (KPIs) related to regulatory activities and compliance.

Veeva Vault and RIM Support:

• Implement and optimize Veeva Vault and RIM systems to ensure efficient regulatory information management.
• Conduct regular audits and data validations to maintain data integrity and accuracy within Veeva systems.
• Provide training and support to regulatory affairs teams on Veeva Vault and RIM applications.

ERP and Business Process Optimization:

• Collaborate with IT and business teams to integrate regulatory processes within ERP systems, ensuring data consistency and process efficiency.
• Analyze and document current regulatory and business processes, identify inefficiencies, and recommend improvements.
• Support change management initiatives related to process enhancements, system implementations, and user adoption.

Compliance and Documentation:

• Ensure all regulatory documentation complies with GxP (Good Practice) regulations and industry standards.
• Develop and maintain process documentation, including standard operating procedures (SOPs), workflows, and user manuals.
• Assist in regulatory audits and inspections, providing necessary documentation and reports.

Qualifications:

• Bachelor s degree in regulatory affairs, life sciences, data science, or a related field; advanced degree preferred.
• Proven experience in regulatory affairs, with a strong focus on data analysis and process optimization.
• Extensive experience with Veeva Vault, particularly in RIM applications.
• Knowledge of ERP systems and their integration with regulatory processes.
• Strong analytical skills with proficiency in data analysis tools (e.g., Excel, SQL, Tableau, Power BI).
• Excellent understanding of regulatory requirements, GxP standards, and industry best practices.
• Strong communication, collaboration, and problem-solving skills.
• Ability to manage multiple priorities in a fast-paced environment.

Regards,

Harsha Jakheriya

Nex Info

USA- (+1) Ext-225 | Direct : (+1)

Web -

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• Dice Id: nexinfo
• Position Id: 8374360

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