Senior Director, Central Regulatory Delivery

At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big, and working together to make the impossible a reality. Our rich and robust pipeline provides the opportunity to work with a variety of ground-breaking medicines across diverse therapy areas and at all stages of the development process. We work to bring medicines to patients as efficiently and effectively as possible to ultimately address unmet needs across the globe. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person!

We are now looking for you who want to join us in the role as Senior Director of Central Regulatory Delivery.

This role will head the Regulatory Central Drug Delivery group, reporting to the Executive Director / Head of Regulatory Technology & Operational Excellence [RTE] group, and working alongside leaders of other pillars on the RTE leadership team. Regulatory Technology & Operational Excellence is a team of 150 professionals working in Sweden, US, Canada, UK, Poland, Spain and India. We have a broad remit to advance regulatory capabilities at AZ through informatics, digital platforms, trusted data and reliable process.

As the Senior Director you will direct a global team that delivers operational services to Regulatory Affairs groups across all therapeutic areas. This role encompasses various accountabilities essential for the effective functioning of regulatory operations within AstraZeneca. Including:

Regulatory Information Management: Lead the management of data within the Enterprise Regulatory Vault (ERV) system to ensure accuracy and compliance.

Annual Reports and License Renewals: Oversee and ensure timely preparation and submission of annual reports and license renewals, maintaining adherence to regulatory requirements.

Dossier Management: Manage the lifecycle of regulatory dossiers, ensuring that all submissions meet the quality standards required by health authorities.

Regulatory Labeling & Artwork: Direct the regulatory labeling and artwork processes to guarantee compliance with regulatory specifications and branding guidelines.

Ownership of Publishing Service: Take charge of the publishing service to ensure all regulatory documents are accurately prepared and submitted.

Additional accountabilities: 

• Lead the development and implementation of global strategies and transformations that align with AstraZeneca's regulatory mission and organizational goals.
• Oversee the central regulatory delivery team to ensure the provision of quality, cost-effective services while continuously improving technical and operational processes.
• Build and maintain effective relationships with key internal and external stakeholders to support strategic alliances and ensure compliance with regulatory requirements.
• Drive recruitment, retention, and development of a diverse and flexible workforce, balancing in-house and outsourced capabilities to meet project and business needs.
• Identify, implement, and manage innovative solutions and tools that enhance efficiency, speed, and transparency in delivery.
• Ensure all activities comply with AstraZeneca’s corporate policies, GxP, external regulations, and industry best practices while fostering an information-based culture.
• Utilize data analytics to track and improve group performance globally, ensuring alignment with business objectives and KPIs.
• Represent AstraZeneca in professional forums and conferences, leveraging expert knowledge to anticipate industry trends and maintain a competitive advantage.
• Maintain awareness of AstraZeneca’s product portfolio to prioritize resources effectively and ensure the availability of expertise to support medicinal product development.
• Actively contribute to the RTE Leadership Team, promoting a culture of collaboration and proactive improvements.

With this in mind we are looking for someone that strives in the role of being a strategic thinker and a visionary leader as well as being operational savvy. You are a strong communicator  and a skilled relationship builder fostering a diverse workforce and nurturing team development. You have the ability to oversee the central regulatory delivery team to ensure the provision of quality, cost-effective services while continuously improving technical and operational processes.

Essential requirements

• Bachelor’s degree or higher
• Minimum of 15 years of experience in the pharmaceutical industry, with significant experience in an international drug delivery role
• Proven experience directing a global team in three or more areas of regulatory operations (e.g., regulatory information, submission/dossier management, regulatory publishing, labeling/artwork, annual reports, license maintenance, or related areas)
• Comprehensive knowledge of the pharmaceutical drug development process
• Advanced understanding of regulatory guidelines and trends relating to Global Regulatory Operations (process, tools, standards)
• Experience in developing and implementing new systems and processes
• Understanding of current, as well as being visionary in, systems & technology utilized for regulatory information
• Ability to operate in both domestic and international arenas
• Capable of managing budget and productivity responsibilities
• Familiarity with GCP, GRP, and other regulatory requirements
• Proven leadership promoting motivation and empowerment of others to accomplish individual, team, and organizational objectives
• Demonstrated development of staff by identifying and providing opportunities to improve the capabilities of team members
• Strategic thinking and judgment, setting vision and expectations with customers, and applying broad business acumen into decision-making
• Demonstrated ability to manage change with a positive approach to the challenges of change for self, team, and the organization
• Excellent negotiation, collaboration, and interpersonal skills
• Strong problem and conflict resolution skills
• Demonstrated ability to set and manage priorities, resources, performance targets, and project initiatives in a global and regional environment
• Demonstrated ability to innovate best practice in Global Regulatory Operations, including experience with business process analysis and design
• Flexibility and ability to thrive in a rapid-paced environment, manage effectively, and make difficult decisions in uncertain/evolving situations
• Ability to initiate and sponsor enhancement projects within the section to build scientific and process-oriented best practices

Why AstraZeneca?

At AstraZeneca, we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science, challenge convention and unleash your entrepreneurial spirit. To embrace differences and take bold actions to drive the change needed to meet global healthcare and sustainability challenges.There is no better place to make a difference in medicine, patients, and society. An inclusive culture where you will connect different thinking to generate new and valuable opportunities. Where you will find a commitment to lifelong learning, growth and development for all.

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.

Interested? Come and join our journey.

So, what’s next?
Are you ready to take the next step in your career and become part of our amazing team? We look forward to receiving your application, no later than 20 April, 2025. Interviews may take place continuously during the advertising period, so do not hesitate to submit your application now

Date Posted

06-apr.-2025

Closing Date

19-apr.-2025

Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.