Description

Regulatory Affairs Manager

About Astellas

Astellas is a general life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at Astellas.com .

Are you driven to make a real difference in the lives of patients?

We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas, and aren't afraid to take intelligent risks. People who act with unwavering integrity and are deeply committed to making a tangible impact.

Location and Working Environment

This position is hybrid and will require you to be onsite minimum 1 day per week in Madrid, Spain office.

Working Hours

This is a full-time & permanent contract.

Purpose & Scope

As a Regulatory Affairs Manager,



you will provide regulatory expertise and lead the execution of local regulatory strategies to support the registration, maintenance, and lifecycle management of Astellas products. You will act as a key contact for local Health Authorities, ensuring the timely preparation and submission of regulatory documentation while supporting business objectives and patient access.

You will manage a broad range of regulatory activities, including Marketing Authorization Applications, variations, notifications, promotional material approvals, and the maintenance of product information and artwork. In this role, you will ensure compliance with Astellas policies, local and regional regulatory requirements, and approved product registrations, helping to maintain the highest standards of regulatory excellence and compliance.

Role And Responsibilities

Support local regulatory strategy and deliver compliant submissions, approvals, and regulatory communications with Health Authorities.
Manage

📌 Regulatory Affairs Manager (Madrid)
🏢 Astellas Pharma
📍 Madrid