Role Summary

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are looking for a Senior Director, Global Development Solutions to join our Digital and Technology team.

The Senior Director Global Development Solutions will provide strategic leadership for Global Development technology capabilities within the Global Capability Center while serving as a trusted partner to business and technology leaders worldwide. This role is responsible for building and scaling high-performing teams while delivering cutting-edge technology, data, AI, and digital solutions that support Clinical Operations, Biostatistics & Data Management, Regulatory Affairs, Quality, Medical Affairs, and Drug Safety functions.

This position requires strong technology leadership, deep knowledge of pharmaceutical development processes, experience leading digital transformation initiatives, and the ability to drive innovation while ensuring regulatory compliance in highly supervised environments.

Key Responsibilities

- Lead and scale the Global Development Digital & Technology organization within the India Global Capability Center while fostering a high-performance, inclusive, and innovation-driven culture.
- Build and expand Global Development technology capabilities through strategic hiring, onboarding, talent development, and organizational design.
- Partner with Global Development and Technology leadership teams to define and implement business-aligned digital strategies that accelerate drug development outcomes.
- Lead end-to-end technology, architecture, data, and AI solution delivery across Agile and traditional delivery models.
- Drive operational excellence through governance, delivery performance metrics, delivery predictability, and continuous improvement initiatives.




- Establish and maintain inspection-ready validation programs aligned with GxP requirements, Computer System Validation standards, and data integrity principles.
- Ensure compliance with applicable regulatory requirements including 21 CFR Part 11, EU Annex 11, ICH guidelines, and evolving global regulations.
- Drive adoption of AI and Generative AI capabilities by identifying and implementing compliant, value-generating solutions across the drug development lifecycle.
- Act as a strategic advisor to senior collaborators by translating scientific and business challenges into scalable technology solutions.
- Communicate effectively with executive leadership and global cross-functional teams to enable alignment and informed decision-making.

Required Skills & Experience

- Bachelors degree in computer science, Information Technology, Engineering, Life Sciences, Business, or a related field; advanced degree preferred.
- Significant leadership experience within pharmaceutical, biotechnology, healthcare, or other highly regulated industries.
- Deep knowledge of drug development functions including Clinical Operations, Biostatistics & Data Management, Regulatory Affairs, Quality, Medical Affairs, and Drug Safety/Pharmacovigilance.
- Experience leading large-scale technology organizations and global delivery teams across architecture, engineering, data, and AI rigors.
- Strong understanding of Global Development technology platforms including CTMS, EDC,



Regulatory Information Management Systems, Safety Systems, Statistical Computing environments, and Clinical Data Repositories.
- Strong knowledge of GxP compliance, Computer System Validation (CSV/CSVa), ALCOA+ data integrity principles, and global regulatory requirements.
- Experience establishing and expanding Global Capability Center organizations or similar global operating models.
- Demonstrated experience evaluating, implementing, and governing AI and Generative AI solutions within regulated environments.
- Proven ability to influence senior collaborators and operate effectively within sophisticated global matrix organizations.
- Strong critical thinking, organizational leadership, organisational change, problem-solving, and executive communication skills.
- Advanced degree or equivalent experience such as MS, MBA, PharmD, or equivalent.
- Experience leading global digital transformation initiatives within Clinical Development or Research organizations.
- Experience working within highly matrixed global organizations across multiple geographies.
- Experience implementing AI-enabled solutions supporting Drug Development functions.
- Strong understanding of cloud platforms, sophisticated analytics, and emerging technologies supporting Global Development.
- Clinical Development Technology Platforms (CTMS, EDC, Regulatory Systems, Safety Systems, Statistical Computing, Clinical Data Repositories).
- Artificial Intelligence, Generative AI, Advanced Analytics, and Data-Driven Solutions.
- Cloud Platforms and Modern Enterprise Architecture.
- Computer System Validation (CSV/CSVa) and GxP Compliance.
- Data Integrity, Governance, Security, and Regulatory Compliance.
- Agile Delivery, Digital Transformation, and Technology Modernization.

📌 Senior Director, Global Development Solutions (Bengaluru)
🏢 Regeneron
📍 Bengaluru