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 Regulatory Affairs Manager (RAM) is a regulatory specialist with project management capabilities responsible for leading the end-to-end planning, coordination, and execution of assigned deliverables. The RAM contributes to regulatory submission strategy, identifying submission risks and opportunities, while leading simple through more complex regulatory applications and managing procedures through approval. The RAM provides regulatory expertise and guidance on procedural and documentation requirements to GRET, GRST and cross-functional teams working flexibly within and across regions to ensure the delivery of business objectives.

Accountabilities/Responsibilities
- Understand the regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regions.




- Provide regulatory input on procedural and documentation requirements as defined by Health Authorities for assigned deliverable(s) including:
- Submission delivery strategy of all dossiers and all application types per market and /or region.
- Review of documents (e.g. response documents, study protocols, PSRs, etc.).
- Analysis of regulatory procedures and special designations used during development, authorizations and extension of the product.
- Use and share best practices, when handling various applications and procedures during interactions with health authorities and in day-to-day work, while operating in a highly dynamic environment.
- Lead and / or contribute to the planning, preparation (including authoring where relevant) and delivery of simple and with experience, increasingly more complex submissions throughout the product’s life cycle from either a general and/or regional perspective.
- Develop, execute and maintain submission delivery plans, submission content plans, and proactively provid

📌 Regulatory Affairs Manager (Barcelona)
🏢 AstraZeneca
📍 Barcelona