Regulatory Affairs Manager

Job Title: Regulatory Affairs Manager

Introduction to role:

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

Are you ready to steer complex, high-impact registrations across international markets and bring transformative medicines to patients with rare diseases? Based in Barcelona, you will drive regulatory strategy and execution for unique, technologically advanced products that address areas of significant unmet need.

In this role, you will connect science, policy, and business to achieve timely approvals and robust lifecycle management. You will partner closely with global and local stakeholders across development, commercial, and medical functions to expand the reach of our portfolio and maintain compliance at every step. Can you see yourself shaping strategy one day and orchestrating a flawless submission the next?

Accountabilities:

• Submission Planning and Delivery: Build, align, and deliver regulatory submission plans for assigned products and programs across International markets to meet business objectives and accelerate patient access.

• Submission Coordination Support: Coordinate timelines, documentation, and cross-functional inputs to ensure complete, accurate, and on-time submissions in line with regional requirements.

• Health Authority Engagement: Prepare for and support strategic interactions with regulatory authorities, enabling clear, consistent positions and positive outcomes for key milestones.

• Regulatory Compliance Assurance: Maintain rigorous adherence to internal standards, local regulations, and global policies, ensuring inspection readiness and reliable documentation.

• Regulatory Intelligence: Monitor evolving regulations and trends across relevant jurisdictions and development stages, and translate insights into actionable guidance for teams.

• Enterprise Collaboration: Provide regulatory input to Commercial, Medical, and other partners to shape evidence generation, claims strategy, and launch readiness for the International region.

• Governance and Process Support: Contribute to internal decision forums and continuously improve regulatory processes, SOPs, and audit/inspection support frameworks.

• Opportunity Identification: Identify and prioritize areas where AI tools can streamline workflows, reduce cycle times, and improve submission quality.

• AI-Driven Solution Development: Design and validate prompt-based and agentic AI solutions that enhance documentation, planning, and data analysis while meeting regulatory quality and compliance standards.

• Leadership and Conduct: Model integrity, transparency, and ethical decision-making in all internal and external interactions, including with Health Authorities.

Essential Skills/Experience:

• 4+ years of relevant Regulatory experience in the pharmaceutical industry.

• Bachelor's degree in a relevant field.

• Strong knowledge of drug development and regulatory policy, couple by excellent scientific and business judgment.

• Experience managing regulatory activities in International markets for the global development of products through one or several stages of development including pre-approval and marketed assets.

• Ability to manage complex issues and coordinate multiple projects simultaneously in a time-sensitive fashion.

• Ability to build intra- and inter-team relationships and collaborate in a global team environment at all levels of the organization.

• Strong interpersonal, and written/verbal communication skills.

• Proven track record practicing sound judgment as it relates to risk assessment

• Understanding of GxPs at relevant areas and solid understanding of where to seek and how to interpret regulatory information.

• Understanding of responsible AI principles such as data privacy, bias mitigation, and compliance requirements relevant to the pharmaceutical and regulatory environment.

Desirable Skills/Experience:

• Bachelor’s Degree, life science highly desirable.

• Postgraduate degrees relevant to the role (e.g. MSc, PhD) a plus.

• Additional certification and/or training relevant to the role over the past.

• Experience working in regulatory documentation system (like Veeva).

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions.

That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

Why AstraZeneca: Here, your regulatory expertise accelerates science into real-world impact for people with serious and rare conditions. You will work with talented colleagues who blend rigor and compassion, using cutting-edge tools and bold cross-functional collaboration to navigate complex pathways and deliver meaningful outcomes. We value kindness alongside ambition; you will find the mentorship, resources, and freedom to explore smarter ways of working—whether you are architecting a pivotal submission package, shaping policy positions, or piloting AI solutions that raise the bar for quality and speed. Your contribution will help turn pioneering biology into medicines that change lives, while building a career defined by purpose and progress.

Call to Action: Join us in Barcelona to lead the regulatory moments that matter—advance your craft, accelerate patient impact, and help write the next chapter of innovation today!

Date Posted

27-jul-2026

Closing Date

09-ago-2026

Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact accommodations@Alexion.com. Alexion participates in E-Verify.