Director Regulatory Process

Join a global science-led company where your work in regulatory process excellence enables faster compliant access to medicines for patients worldwide!

We are looking for someone that would like to join our Regulatory Process team as Director within Regulatory Process.

This is an opportunity to work at the intersection of process data and technologypartnering across groups and systems to modernise how we operate and drive continuous will be able to collaborate with internal stakeholders across regions and functions opportunity to engage with health authority industry group and vendor initiatives to shape best-in-class regulatory practices.

At AstraZeneca every one of us plays a part in bringing life-changing medicines to patients. We are driven by science united by our purpose and motivated by the opportunity to make a meaningful difference for people society and the planet. We foster an inclusive innovative environment where you can thrivegrowing your career while shaping the future of health. If you are passionate about transforming how global regulatory processes deliver patient impact this is the place to do it.

As a Director Regulatory Process you will steward a nominated area within Regulatory Processessuch as Clinical Trial Applications Labelling Marketing Applications License Maintenance or Regulatory Information Management. You will own the end-to-end lifecycle of processes in your area: from design and development through implementation continuous improvement and customer supportensuring compliance with applicable industry regulations and AstraZeneca Global and Local Policies. You will build strong relationships across Regulatory Affairs and relevant functions to execute strategy govern current procedural documents and deliver measurable business benefits.

What youll do

• Own and be accountable for the long-term stewardship and successful delivery of business benefits across your nominated group of processes.
• Fulfil all responsibilities of the Business Process Owner (BPO; when tasks are delegated retain accountability for setting and communicating strategy and timelines.
• Demonstrate and foster a culture of ownership and holistic efficient issue management that meets business needs and ensures top-tier customer and stakeholder engagement.
• Engage and influence key internal and external stakeholders (also beyond Regulatory) to drive strategy development and continuous improvement of processes technology and services.
• Ensure customer requirements are understood critically evaluated prioritised and addressed; partner with line managers and leadership to align needs and resources and provide clear rationale for non-addressed areas.
• Ensure internal processes are fit for purpose and lead improvements with relevant stakeholders.
• Partner with Systems counterparts to drive an integrated holistic approach across processes and systems.
• Act as the primary escalation point for risks and issues within the assigned area.
• Monitor overall performance of processes and technology; track KPIs oversee timely and quality CAPAs and act on insights from Quality & Risk Management.
• Actively seek and promote creative innovative ideas that drive performance and bring new solutions to customers.
• Project manage to agreed targets and provide expert operational and/or strategic regulatory or pharmacovigilance input to cross-functional teams.
• Ensure relationships and interfaces are managed effectively across internal teams and with external partners.

Essential requirements

• University degree or equivalent qualification in a relevant scientific discipline.
• Knowledge and understanding of global regulatory and pharmacovigilance requirements balanced with industry standards to achieve business goals.
• Experience in design development implementation maintenance continuous improvement and customer support for business processes in the area of focus.
• Experience authoring standards documents (e.g. Standard Operating Procedures).
• Experience developing and delivering training via virtual meetings and other media.
• Experience leading teams as a line manager or project lead.
• Ability to manage multiple stakeholders effectively.
• Extensive knowledge and skills in project management specifically in leading teams.
• Demonstrated excellent written and verbal communication skills.
• Able to work with a high degree of autonomy.
• Able to represent AstraZeneca externally where required.

Desirable requirements

• PhD in a scientific discipline.
• Knowledge of new and developing regulatory and pharmacovigilance expectations.
• Experience with inspection activities.

Key capabilities

• Understanding of governance processes.
• Process improvement expertise (e.g. Lean methodology).
• Strong collaboration and coordination skills.
• Financial acumen and resource prioritisation.
• Ability to drive outcomes across matrix teams.
• Open to multiple perspectives with a balanced solution-focused approach.

So whats next

If this sounds like you were ready to hear your story and explore how you can help us advance regulatory excellence and deliver for patients.

Were looking forward to your application!

Date Posted

Closing Date