Regulatory Affairs Portfolio Director

Location: Barcelona - Spain (3 days working from the office and 2 days working from home)

Introduction to role:
Are you ready to lead and inspire in the world of regulatory affairs? As a Regulatory Affairs Portfolio Director, you'll be at the forefront of driving strategic leadership, managing complex global regulatory projects, and fostering continuous improvement. This dynamic role combines line management, drug project leadership, and cross-project responsibilities, offering a unique opportunity to shape the future of regulatory affairs. You'll manage a team of regulatory professionals, contribute to strategic direction, and ensure high-quality operational delivery. With your expertise, you'll tackle critical leadership roles in high-priority projects, influence global teams, and drive accelerated delivery plans. Are you prepared to make a difference?

Accountabilities:
• Provide leadership, coaching, and line management for 4-20 direct reports, developing staff to their full potential.
• Proactively contribute to the strategy and efficient operation of the TA Regulatory group.
• Assign RAM resources to meet project needs in collaboration with leadership teams.
• Manage budget and headcount, aligning with global portfolio changes.
• Ensure compliance with AZ standards and policies.
• Support individuals with regulatory knowledge at global and regional levels.
• Drive a culture of continuous improvement and knowledge sharing.
• Collaborate globally to enhance RAM capabilities and improve systems and processes.
• Influence the external image of the business.

Essential Skills/Experience:
• University Degree in Science or a related discipline
• Extensive regulatory experience within the biopharmaceutical industry, or experience at a health authority
• Knowledge of regulatory procedures and legislation for drug development, throughout the product lifecycle
• Proven successful leadership and project management experience 
• Proven ability to develop others to meet personal aspirations and business needs
• Proven ability to drive and implement change and improvement projects 
• Strong influencing, stakeholder management and negotiating skills
• Excellent written and verbal communication skills
• Proficiency with common project management tools and methodology.
• Managed first wave Marketing Application and/or LCM submissions 
• Managed complex regulatory deliverables across projects/products

Desirable Skills/Experience:
• Knowledge of AZ business and processes.
• Facilitation skills
• Resource management

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.

At AstraZeneca, we are driven by innovation and collaboration. Our inclusive environment empowers you to take smart risks and uncover creative solutions. Working on Oncology products means addressing unmet needs with innovative approaches, transforming breakthrough science into life-altering solutions. We thrive in a globally connected environment where learning is shared across locations and therapy areas. Here, you'll have the autonomy to be an agent of change, benefiting from global opportunities to develop in multiple roles. Join us in making a real impact on patients' lives.

Ready to take on this exciting challenge? Apply now to become part of our transformative journey!

Date Posted

25-jun-2025

Closing Date

18-jul-2025

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

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AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.