Experteer Overview

Se anima a todos los posibles solicitantes a que se desplacen y lean la descripción completa del puesto antes de presentar su candidatura.

As Regulatory Affairs Manager in Barcelona, you will oversee end-to-end regulatory planning, coordination, and execution for assigned deliverables. You will shape submission strategy and identify risks and opportunities across regions, leading simple to complex regulatory applications. You will collaborate with cross-functional teams, ensuring alignment with Health Authority requirements and timely delivery of documents and plans.

This role offers impact through global/regional submissions, process improvements, and mentoring within the RAM group, in a dynamic, growth‑minded environment.

Compensaciones / Beneficios

- Plan and deliver submissions across markets/regions, defining strategy and timelines
- Coordinate input, maintenance and revision of Planit project plans; flag resource changes
- Prepare and review regulatory documents (protocols, PSRs, responses)



and ensure alignment with health authority requirements
- Lead or contribute to life‑cycle submissions from integral and/or regional perspectives
- Identify regulatory risks and propose mitigations to senior stakeholders
- Support TMF and document management activities with CROs, alliance partners, and internal teams
- Provide coaching and knowledge sharing within RAM group
- Contribute to process improvements
- Facilitate cross‑functional interactions with health authorities and internal xugodme teams

Responsabilidades

- Bachelor in Regulatory Sciences or related scientific field
- 3+ years regulatory experience in biopharma or health authority
- General knowledge of drug development
- Strong project management and leadership experience
- Ability to work independently and in cross‑functional teams
- Excellent written and verbal communication
- Knowledge of MS Project and document management tools

Requisitos principales

•

📌 Regulatory Affairs Manager (Barcelona)
🏢 AstraZeneca
📍 Barcelona