Dir. DDIT Dev Regulatory Affairs

Summary

Job Title: Director, DDIT Development - Regulatory Affairs
#LI-Hybrid
Location: Barcelona, Spain
Relocation Support: This role is based in Barcelona, Spain. Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.

Imagine shaping how regulatory teams worldwide harness technology to deliver medicines faster, smarter, and with confidence. As Director, DDIT Development - Regulatory Affairs, you will be the strategic technology partner to the Regulatory Affairs organization, turning complex business priorities into a high-impact digital and technology roadmap. You will lead a global portfolio that connects strategy, architecture, and execution-empowering leaders with clear insights, enabling innovation, and ensuring technology consistently advances regulatory excellence and patient outcomes.

About the Role

Key responsibilities:

• Act as the primary technology partner to Regulatory Affairs leaders, shaping strategy and digital priorities.
• Own the Regulatory Affairs technology portfolio, including governance, processes, metrics, and decision frameworks.
• Drive prioritization across initiatives using value, feasibility, impact, and capacity considerations.
• Oversee portfolio delivery, ensuring timelines, budgets, quality, and benefits realization.
• Lead development of business cases and project plans aligned to the Regulatory Affairs technology roadmap.
• Establish transparent reporting using key performance indicators and actionable portfolio insights.
• Anticipate risks, address delivery challenges, and drive timely resolution through stakeholder alignment.

Essential requirements:

• 10+ years of experience leading global technology or digital transformation in pharmaceutical or healthcare environments.
• Strong expertise in strategic technology partnering and project portfolio management.
• In-depth knowledge of software development life cycle and Agile Scrum delivery models.
• Proven experience applying artificial intelligence in life sciences, including large language models and retrieval-augmented generation.
• Demonstrated success leading complex programs with strong risk management and prioritization skills.
• Excellent leadership, analytical thinking, and executive-level communication across technical and non-technical audiences.

Novartis is committed to building an outstanding, inclusive workplace and diverse teams representative of the patients and communities we serve.

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

Benefits and Rewards: Learn about all the ways we'll help you thrive personally and professionally.
Read our handbook (PDF 30 MB)