Introduction to role:

This role is based in Barcelona, with an on-site commitment of three days a week. Fluency in English is required.

The Associate Regulatory Affairs Director (ARAD) is an experienced regulatory specialist with strong project management experience and a track record of advancing innovative therapies through key clinical development milestones.

As a key member of the global regulatory strategy team (GRST), you are responsible for partnering with senior regulatory experts to support the end-to-end regulatory strategy planning, coordination, and execution of assigned cell therapy projects. The ARAD is solutions-oriented and a key contributor to regulatory strategy development, the identification of submission risks and opportunities, and drives high quality integral regulatory authority engagements and submissions. The ARAD provides regulatory expertise and guidance on the clinical development requirements, including procedural and documentation requirements to regulatory and cross-functional teams,



working flexibly within and across regions to achieve business objectives.

Accountabilities/Responsibilities
- Partner closely with members of the global regulatory team, to define stage appropriate regulatory strategy in alignment with global regulatory requirements and expectations, to bring innovative cell-based gene therapies to patients.
- Closely monitor evolving global and regional regulatory guidelines, policies, and procedures to support efficient, scientifically rigorous, and patient-centric development plans.
- Lead and contribute to the planning, preparation, review, and submission of regulatory submissions (e.g., IND, CTA, GMO, BLA, IVDR) s for cell-based gene therapies across all regions, ensuring proper documentation and compliance with internal and external standards.
- Advise the regulatory and cross-functional teams of available opportunities to accelerate development by evaluating risks and identifying potential solutions to address r

📌 Associate Regulatory Affairs Director (Barcelona)
🏢 AstraZeneca
📍 Barcelona