Barcelona-Based Global Regulatory Affairs Manager

AstraZeneca GmbH; Barcelona; Presencial; EUR 65.000 - 95.000; Jornada completa

Descripción de la vacante

AstraZeneca is seeking a Regulatory Affairs Manager in Barcelona to lead international regulatory strategy and submissions. The role is office-based with three days on-site per week, and requires fluency in English.

You will interact with global teams to enable timely approvals, lifecycle management, and compliance across markets. You will drive regulatory planning, coordinate cross-functional inputs, and foster AI-enabled improvements while upholding GxP and ethical standards in a dynamic,

Formación

• 4+ years of regulatory experience in pharma.

Responsabilidades

• Develop and deliver regulatory submission plans for international markets.
• Coordinate timelines and documents for timely submissions.
• Prepare for interactions with health authorities to enable positive outcomes.
• Ensure compliance with internal standards and global policies.
• Monitor regulatory trends and translate into guidance.
• Collaborate with Commercial, Medical and other partners for launch readiness.
• Contribute to governance, SOPs, and audit support.
• Identify opportunities to apply AI to streamline workflow and submissions.
• Design and validate AI-enabled regulatory tools for docs and planning.
• Model integrity and ethical decision-making in regulatory work.

Conocimientos

Regulatory strategy

Global submissions

Cross-functional collaboration

GxP knowledge

Regulatory intelligence

Educación

Bachelor's degree (life sciences)

Postgraduate degree (MSc/PhD) a plus

Herramientas

Veeva

Descripción del empleo

AstraZeneca is seeking a Regulatory Affairs Manager in Barcelona to lead international regulatory strategy and submissions. The role is office-based with three days on-site per week, and requires fluency in English.

You will interact with global teams to enable timely approvals, lifecycle management, and compliance across markets. You will drive regulatory planning, coordinate cross-functional inputs, and foster AI-enabled improvements while upholding GxP and ethical standards in a dynamic,