The Role
The Director of Regulatory Affairs leads technology strategies and digital transformations for regulatory teams, ensuring delivery of a robust technology portfolio while managing governance and stakeholder relationships.
Summary Generated by Built In
Job Description 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.
Job Description
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.
Skills Desired
Business Transformation, Project Management, Regulatory Affairs, Stakeholder Partnerships, Strategic Planning, Talent Development, Technical Analysis, Technology Strategies, Transformation Programs, Waterfall Model
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The Company
What We Do
Novartis is an innovative medicines company. Every day, working to reimagine medicine to improve and extend people’s lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach more than 250 million people worldwide.
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