Experteer Overview
In this role you will support global regulatory strategy within a therapeutic-area structure, coordinating regulatory submissions and life-cycle activities with Health Authorities and cross-functional teams. You will help streamline regulatory processes, identify risks, and ensure timely approvals for regional and international development. The position offers exposure to global collaboration, regulatory affairs leadership, and meaningful work that supports patient access and product lifecycle management. You will contribute to shaping regulatory strategies across regions and maintaining alignment with global functions.

Compensaciones / Beneficios
• Standardize RA Strategy processes across international and ICH regions to streamline submissions
• Develop regulatory strategies for Health Authority submissions in assigned regions
• Support country or regional Regulatory Affairs for international development
• Identify major regulatory issues early and coordinate responses
• Act as primary interface with Health Authorities and regional Regulatory Affairs colleagues
• Coordinate international regulatory input into lifecycle management for projects
• Ensure robust feedback and approvals from regional and global functions




• Identify corrective regulatory actions to protect global pharma goals
• Consolidate regulatory strategy elements to achieve project milestones
• Ensure information exchange with regions for regulatory requirements assessment
• Identify and communicate regulatory risks and mitigations to stakeholders

Responsabilidades
• University degree in a technical discipline or life sciences; Master or Bachelor with longer industry experience
• Several years of regulatory, clinical trials, or biomedical research experience
• Experience in the pharmaceutical industry
• Knowledge of Veeva RIM is beneficial
• Understanding of drug development, regulatory guidance, and license variations in main/assigned countries; medical writing awareness
• Effective communicator with basic project management skills
• Fast learner, open-minded, and able to challenge status quo
• Ability to work in a global, multicultural team
• Fluent in English; additional languages helpful

Requisitos principales
• hybrid model
• potential for variable pay/bonuses
• equal pay considerations
• discretionary salary components
• versátil work arrangements

📌 Junior Global Regulatory Strategist (Barcelona)
🏢 Bayer
📍 Barcelona