Regulatory Affairs Portfolio Director

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

Introduction to role:

This role covers a combination of line management, drug project leadership and cross-project responsibilities. The proportion of each element which is expected at any one time, will vary between individuals and will be adjusted for an individual depending on workload and to meet business and portfolio needs. 

As a line manager an individual is responsible for recruitment and line management of 4-20 regulatory professional staff. In addition, they will contribute to the strategy, direction and efficient operation of the Regulatory TA organisation as well as the RAM community. They will also provide regulatory expertise and oversight to ensure high quality drug project operational delivery and efficiency by the group.   

As an experienced regulatory specialist with strong project management capabilities, an individual can also take on critical leadership roles for particularly complex and high priority global regulatory projects and / or major submissions. Typical capabilities required are to develop and maintain successful strategic and collaborative relationships, to proactively influence and negotiate across local and global teams and to independently resolve issues and drive accelerated delivery plans.  

In addition, they will provide regulatory expertise and guidance on procedural and documentation requirements to all collaboratorsand cross-functional teams, working flexibly within and across regions to ensure the delivery of business objectives globally 

In addition, an individual can also take on responsibility as subject matter expert to help drive continuous improvement or change project.  

Typical Accountabilities 

• As a line manager, provide leadership, coaching and line management for 4-20 direct reports. Ensure the principles of both individual and team performance development are used to develop staff to their full potential. 

• Attract and recruit talent. Be an ambassador for the RAM group, able to engage collaborators and clearly articulate the RAM roles and responsibilities. 

• As a leader within the TA Regulatory group, proactively contribute to the strategy, direction and efficient operation of the group. Support development and deliver departmental performance targets for the TA Regulatory organisation.  

• Assignment of capable RAM resources to meet the drug project and improvement project needs in collaboration with the wider Regulatory TA leadership team, Lead RPMs and Director, Delivery Excellence, ensuring cost effective and flexible resource management which is aligned with TA priorities and specific Global Regulatory Execution Teams(s) (GRET(s)) as required. 

• Contribute to management of the budget and head count, identifying budget priorities taking careful note of global portfolio changes and business needs. 

• Ensure own work and work of direct reports and GRETs adheres to and remains in compliance with AZ standards, processes, AZ group policies and corporate responsibilities.  

• Has an in-depth regulatory knowledge and understanding of RAM roles, Submission Excellence and Regulatory Operating Model and can support individuals as needed with typical activities at a global and/or regional level to ensure delivery of project objectives on time and to appropriate quality.   

• Drive a culture of continuous improvement, learning and knowledge sharing. 

• Contribute to continuous improvement of expert and/or process area and/or drug project work. 

• Support wider global regulatory organisation (cross TA and centrally) by collaborating with the lead Director, Delivery Excellence, to drive the development of groundbreaking RAM capabilities as well as system and process improvement driving productivity gains.  

Within a drug project leadership role, your responsibilities could include, but are not limited to: 

• Drive and lead delivery focused teams, e.g., GRET (Global Regulatory Execution Team), RSDT (Regulatory Submission Delivery Team). Assume overall accountability for the planning, forecasting and reporting, utilising refined project and partner management skills, ensuring optimised delivery of regulatory activities to time and quality. 

• Be a core member of strategy teams, e.g. GRST (Global Regulatory Strategy Team) and RSST (Regulatory Submission Strategy Team), successfully collaborating with key partners, challenging and contributing to ensure optimised delivery of regulatory strategy plans from Candidate Drug (CD) nomination through to submissions and approval to achieve critical milestones and scorecard goals. 

• Ensure all compliance activities for the project/product are completed and maintained.  

• Identify regulatory risks, opportunities and proactively develop mitigation strategies for operational regulatory activities, e.g. planned submissions, (with input from all team members). 

• Facilitate partner management and communication within Regulatory, cross functionally and across collaborations. 

As a senior member of the RAM community:

• Be a recognized expert in the current regulatory environment. Understand the regulatory framework, including regional trends for various types of applications, procedures and documents, with experience in Vaccines & Immune Therapies (the infectious disease/biologicals space) with a particular focus on planning, delivery and project management. 

• Be well versed in the AZ Regulatory Operating Model and AZ Drug Development Process 

• Be a role model for AZ Values & Behaviors and a visible, approachable leader and role model for the RAM community.  

• Lead and/or contribute to the planning, preparation and delivery of key regulatory activities, e.g. major submissions throughout the product’s life cycle from a global and/or regional perspective. 

• May assume assigned responsibilities for routine and non-routine contact with health authorities and marketing companies.  

• Work in partnership with Director, Delivery Excellence and the V&I RA LT to identify and help drive opportunities for improvements, simplifications, best practices across the RAM community and the RA organization  

Minimum Qualifications:

Desirable Qualifications:

• Experience in infectious disease drug development (Vaccines & Monoclonal Antibodies)

• Facilitation skills

• Resource management 

Why AstraZeneca?
At AstraZeneca, we are changemakers on the world stage, leading the way into the future with energy and drive. Our commitment to transforming healthcare is backed by deep knowledge and experience in our field. We invest in groundbreaking collaborations and commercial initiatives to make essential breakthroughs. Our people-first approach challenges the norm, harnessing science and technology to shape care for the future. We embrace diversity as our strength, empowering everyone to share ideas and push boundaries. Join us in making a meaningful difference in the world.

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.