AstraZeneca

Associate Director I/II, Regulatory Analytics

India - Bangalore Full time

Job Title: Associate Director I/II, Regulatory Analytics

Global Career Level: E

Introduction to role

The Associate Director, Regulatory Analytics plays a key role within AstraZeneca’s Regulatory Technology & Operational Excellence (RTE) and Regulatory Data and Analytics (RDA) function. This position is responsible for driving the delivery, design, development, and ongoing enhancement of analytics and reporting solutions for the Regulatory Information Management Systems (RIMS) platform, directly supporting the Regulatory Affairs function.

Leveraging expertise in data analytics, visualization, reporting technologies, and AI, you will supervise a high-performing technical team to deliver impactful solutions. Close partnership with the RDA Technical Lead, RDA Team Manager, and the Product Owner for the RIM Reporting Toolset is central to the role, ensuring timely delivery of solutions and improvements, planning milestones, and setting objectives that align with business goals and support benefits realisation.

In addition, you will advance AstraZeneca’s regulatory capabilities by producing actionable insights and supporting senior regulatory leadership in decision-making. You will contribute to translating regulatory data into strategic recommendations, champion data-driven innovation, and ensure analytics activities adhere to internal policies, regulatory standards, and global industry best practices. You will foster efficient collaboration across cross-functional teams and drive the ongoing evolution of analytics methods and tools in the regulatory domain.

Accountabilities

Regulatory Data Analytics Design and Development

  • Drive the design, delivery, and ongoing enhancement of analytics and reporting solutions for Regulatory Information Management Systems (RIMS) to meet Regulatory Affairs requirements. Translate data findings into actionable regulatory strategies and champion data-driven decision-making across the function. Proactively respond to ad-hoc data requests for audits and inspection readiness, driving improved data interoperability and operational efficiency throughout the organization.

Advanced Data Model and Visualization Development

  • Design, implement, and maintain scalable data models, advanced visualizations, and interactive dashboards that provide actionable insights for senior regulatory leadership and project teams. Act as delegated Product Owner for assigned reporting solutions and analytics dashboards, ensuring alignment with evolving business needs. Lead and mentor the team in data modelling, programming, regulatory data management, and solution architecture.

Agile Project Management

  • Manage development and maintenance efforts using agile methodologies, including Kanban board management. Supervise and mentor a team of analytics developers, fostering collaboration, innovation, and high standards of quality. Work closely with the Product Owner for the RIM Reporting Toolset, RDA Technical Lead, and RDA Group Manager to ensure strategic alignment, efficient resource allocation, and the timely delivery of solutions.

Stakeholder Collaboration and Management

  • Engage with diverse cross-functional teams—including Regulatory, IT, M&A, Quality, Clinical, Safety, Operations, and Marketing Companies—to gather, analyse, and integrate regulatory data supporting submissions, compliance activities, audits, and inspections. Leverage data-driven insights to inform decision-making and enhance compliance objectives.

Continuous Improvement and Change Management

  • Champion the adoption of agile methodologies and foster innovation in analytics approaches and toolsets. Ensure delivery of forward-looking solutions that accelerate regulatory submissions and compliance, while anticipating future business requirements in partnership with senior stakeholders.

Essential Skills/Experience

  • A minimum of 10 years of relevant professional experience is required.

  • Advanced degree (BSc, MSc, or equivalent) in computer science, Information Systems, Data Analytics, Engineering, Life Sciences, or a related technical discipline.

  • Proven proficiency in analytics platforms (such as Snowflake, Power BI, Power Automate or equivalent).

  • Extensive experience with data modelling, data integration, and visualization tools.

  • Strong programming skills (e.g. SQL, Python, VBA, or similar) for data extraction, manipulation, and building analytics solutions.

  • Proven experience in regulatory affairs within pharmaceuticals or a related life sciences industry, with considerable hands-on analytics or data management responsibilities.

  • Proven experience in designing, building, and deploying AI/ML solutions with a strong grasp of data quality, security, and responsible AI principles.

  • Excellent communication and stakeholder management skills, including working with senior managers and external partners.

Desirable Skills/Experience

  • Experience with Regulatory Information Management Systems (RIMS) and familiarity with global regulatory requirements.

  • Certification(s) in project management (e.g., PMP, PRINCE2), advanced analytics, or data science.

  • Knowledge of cloud data solutions (e.g., Azure, AWS, Google Cloud Platform), including data security, governance, and compliance.

  • Involvement in external industry forums or professional societies in data analytics or regulatory technology.

  • Experience with mergers and acquisitions (M&A) or business transformation projects.

  • Record of driving digital innovation, ideally in highly regulated environments.

  • Proven experience in change management, continuous improvement, or process optimization.

  • Demonstrated ability to manage projects using agile methodologies (Kanban, Scrum).

Key Relationships to reach solutions

Internal (to AZ or team)

  • R&D IT, Regulatory Affairs

  • Product Owners and Business Analysts

  • Quality, Clinical, and Safety Functions

  • Marketing Companies

  • Operations, M&A, and Transformation Teams

External (to AZ)

  • Third-party technology vendors and service providers

  • Regulatory authorities and external auditors

  • Industry consortia and professional forums

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

At AstraZeneca, we are part of the solution, turning our drug development strategies into reality. We work at all stages of development to translate our life-changing science into medicines that get the best results for patients in need. Our innovative mindset drives us to think broadly about patients' needs while managing balanced risks. We are valued for our influential work in shaping drug development strategies that lead to fast, efficient approvals. Our diverse team is empowered to make quick decisions while being supported by leaders who remove barriers. We are committed to continuous improvement, always seeking better ways to realize our pipeline.

Ready to make a difference? Apply now!

Date Posted

18-Dec-2025

Closing Date

04-Jan-2026

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.