Regulatory Affairs Head Spain

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:

Regulatory Affairs Group

Job Sub Function:

Regulatory Affairs

Job Category:

People Leader

All Job Posting Locations:

Madrid, Spain

Job Description:

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

Role Overview

The Head of Regulatory Affairs leads the strategic regulatory function within the Spanish affiliate, ensuring solid alignment with EMEA and Global Regulatory Affairs (GRA). This role combines internal leadership with external influence, shaping the regulatory environment to enable successful market access, lifecycle management, and compliance for JJIM products and the commercial and medical activities associated with them.

Key Responsibilities

Strategic Leadership & External Engagement

• Represent JJIM in high-level regulatory discussions with Health Authorities and trade associations.
• Influence regulatory policy and shape the external environment in line with EMEA strategy.
• Provide local regulatory insights to regional teams, shaping the plans accordingly.

Regulatory Affairs Management

• Oversee regulatory submissions, approvals, and lifecycle updates.
• Align local regulatory objectives with EMEA/GRA priorities.
• Ensure readiness for legislative changes and maintain inspection readiness.

Team Leadership

• Lead and develop a high-performing Regulatory Affairs team.
• Drive talent development, performance management, and functional excellence.
• Foster a culture of excellence, accountability, innovation, and continuous improvement.

Cross-Functional Collaboration

• Partner with CVTs and internal departments (Medical, Market Access, Commercial, Commercial Quality) to integrate regulatory strategy into business planning.
• Support tender processes and promotional material reviews.

Compliance & Regulatory System

• Ensure robust compliance with pharmacovigilance, HCC, and legal standards.
• Maintain systems to track regulatory obligations and ensure audit readiness.

Qualifications

• University degree in Life Sciences (Pharmacy, Biology, Chemistry).
• 7+years in Regulatory Affairs, Quality, or other compliance-related areas
• Previous experience in Regulatory affairs is preferable
• 3+ years in external stakeholder engagement and people management is preferable
• Proven experience with Health Authorities and industry associations.
• Strong knowledge of local and regional regulatory frameworks.
• Fluent in Spanish and English; excellent communication and strategic thinking skills.

Location & Travel

• Based in JJIM Madrid HQ, with JnJ flex working schedule.
• Travel as required (max 20%), based on business needs.