Regulatory Affairs Manager
About Astellas
Astellas is a global 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 product information, artwork, and regulatory databases, ensuring accuracy, compliance, and timely updates.
- Review and approve promotional materials in line with local regulations, company policies, and industry codes.
- Partner with cross-functional teams to support product lifecycle activities, and process improvements.
- Monitor regulatory developments and provide insights to support compliance, risk management, and business objectives.
Required Qualifications
- Previous Regulatory Affairs experience within the pharmaceutical industry.
- Experience managing registrations, lifecycle activities, variations, promotional materials, and regulatory strategy.
- Strong understanding of the regulatory function and its impact on cross-functional brand teams.
- Ability to work autonomously, prioritize effectively, and adapt in a fast-paced environment.
- Excellent collaboration and stakeholder management skills, with a strong team-oriented approach.
- Fluent in both Spanish and English.
Preferred Qualifications
- Scientific degree (e.g., Pharmacy, Life Sciences, Chemistry, Biology) or equivalent.
What awaits you at Astellas?
- Global collaboration: Become part of a connected global business of like-minded life science leaders, all dedicated to improving patients' lives worldwide.
- Real-world patient impact: Contribute to transformative therapies that reach patients around the world, knowing your work makes a difference every day.
- Relentless Innovation: Join a company at the forefront of scientific breakthroughs, where you'll have the opportunity to shape the future of healthcare.
- A Culture of Growth: Chart your own course within a supportive environment that values your contributions, champions your development, and empowers you to pursue your passions.
Our Organizational Values and Behaviors
- Impact
- Innovation
- Integrity
- One Astellas
- Accountability
- Courage
- Sense of Urgency
- Outcome Focus
Benefits
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
Beware of recruitment scams impersonating Astellas recruiters or representatives. Authentic communication will only originate from an official Astellas LinkedIn profile or a verified company email address. If you encounter a fake profile or anything suspicious, report it promptly to LinkedIn's support team through LinkedIn Help.
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