Senior Associate - Regulatory Data & Analytics

and executive level stakeholders who utilize Regulatory and Master data across processes and systems. This role will support the delivery of key analytics, reporting, and insights.

Roles & Responsibilities:

• Integrate, clean, and prepare data from diverse systems including but not limited to Data Lakes, Data Warehouses, Databricks, Veeva RIMS / Veeva Vault etc.

• Apply statistical methods or machine learning techniques to support analysis & predictions across product lifecycle milestones

• Develop and maintain executive-level dashboards focused on product lifecycle milestones, enabling trend analysis, risk identification, and informed decision-making at the leadership level

• Delivering quality and compliance in global regulatory data analytics services across processes and systems

• Aid alignment with international data standards to ensure compliance with Health Authority regulations for submission and registration

• Execute and deliver on identified Regulatory Data & Analytics requirements in collaboration with stakeholders

• Contribute to implementation of strategy aimed at alignment with new and existing Regulatory Data Standards, Analytics, and Reporting

• Deliver against defined standards to scale data and usage with repeatable processes to keep data up to date

• Leverage global regulations to support system and process simplification, automation and innovation

• Organize and present data in user friendly, graphical, interactive informational summaries that illustrate how GRAAS is performing and allow us to understand and improve business performance

Required Knowledge and Skills:

• Strong knowledge of data analytics, data visualization, data storytelling and reporting

• Demonstrated experience supporting data and analytics initiatives

• Experience in delivering data-centric processes and systems

• Strong Knowledge of working with and handling structured and unstructured data

• Demonstrated ability to support change management and stakeholder engagement in a regulated environment

Preferred Knowledge and Skills:

• Strong understanding of Regulatory Affairs business complexity and process interdependencies

• Experience with regulatory master data in Regulatory Affairs, Research, Development, Quality Management, or related area

• Demonstrated experience in collaborating with high-performing teams

• Proficiency in data visualization tools or packages, such as Power BI in addition to data pipeline automation tools including Amazon Web Services (AWS), Databricks, Python, SQL etc.

• Strong understanding of web-app development to further support build and delivery of web-based analytical systems, such as web-based dashboards

Basic Education and Experience:

• Doctorate degree and 2 years of regulatory systems and data experience OR

• Master's degree and 4 years of regulatory systems and data experience OR

• Bachelor's degree and 5 years of regulatory systems and data experience OR

• Associate's degree and 8 years of regulatory systems and data experience OR

• High school diploma / GED and 8+ years of regulatory systems and data experience

Preferred Education and Experience:

• Experience supporting data strategy initiatives across a large enterprise

• Understanding of KPI tracking and contributing to deliverables

• 4+ years' experience in Regulatory Affairs

.