Experteer Overview

Obtenga más información sobre las tareas generales relacionadas con esta oportunidad a continuación, así como sobre las habilidades requeridas.

In this role in Barcelona you will lead regulatory strategy and execution for innovative medicines across international markets, driving timely approvals and robust lifecycle management. You will collaborate with global and local teams spanning development, commercial, and medical to expand access while maintaining compliance. You’ll shape strategy and orchestrate high-quality submissions, contributing to a mission of delivering transformative therapies to patients with unmet needs.

You will explore AI-enabled improvements to streamline regulatory processes and boost submission quality.

Compensaciones / Beneficios

- Build and align regulatory submission plans for international markets
- Coordinate timelines and cross-functional inputs for on-time, complete submissions
- Prepare for and support interactions with Health Authorities
- Maintain compliance with internal standards and integral policies; ensure inspection readiness
- Monitor regulatory trends and translate into actionable guidance
- Provide regulatory input to Commercial, Medical, and other teams for evidence generation and launch readiness




- Contribute to governance, SOPs, and audit/inspection support frameworks
- Identify and prioritize AI opportunities to streamline workflows and reduce cycle times
- Design and validate AI-based solutions to improve documentation, planning, and data analysis
- Demonstrate leadership with integrity and ethical decision-making
- Support continued regulatory process improvements and decision forums

Responsabilidades

- 4+ years of regulatory experience in the pharmaceutical industry

��� Bachelor's degree in a relevant field

- Strong knowledge of drug development and regulatory policy; solid xugodme scientific and business judgment
- Experience managing regulatory activities in international markets across development stages
- Ability to manage multiple complex projects and tight timelines
- Ability to build cross-functional relationships in a global team
- Excellent written and verbal communication skills
- Good risk assessment and judgment in regulatory contexts
- Understanding of GxPs and how to find and interpret regulatory information
- Understanding of responsible AI principles including data privacy and bias mitigation

Requisitos principales

•

📌 Regulatory Affairs Manager (Barcelona)
🏢 Alexion Pharmaceuticals
📍 Barcelona