Group Director Regulatory Process

Group Director Regulatory Process

Warsaw, hybrid work (3days from office, 2 days from home per week)

Introduction to role:

As the Group Director Regulatory Process, you will be leading a team of skilled & specialist Process Management professionals who will manage, deliver and actively drive continuous improvement of Regulatory Processes and Procedural documents. You will be closely working with Process Leads and other internal stakeholders to improve ways of working and optimal resource utilisation to deliver better experiences for our customer groups.   

About the role:

You will be leading, and conduct all Line Manager accountabilities, for a team that comprise of Associate Directors and Managers, Regulatory Processes. Drive Skills development by sharing knowledge and mentoring of team. Define and deliver cycle of annual objectives, hiring, training, coaching, and career development of staff.

You will also drive sub-departmental Leadership meetings and people related processes (Capacity Planning, Talent Mgt, RDP etc.). Manage and optimize relationships with key customer groups in regulatory and relevant other internal interfaces (e.g. R&D QA, other process ownership-oriented groups).

Depending on experience, may be accountable for Process Strategy for a sub-process area and/or cross-process initiatives requiring project management and leadership (e.g Integration of acquired company procedures).

Typical Accountabilities:

Accountabilities:

Leading the Process Management Team

• Leading a team of process management professionals, providing guidance and support, ensuring team's success.
• Allocate resources against “book of work” for Regulatory Process management team, aligning personnel with business priorities and individual development goals. Ensure cost effective and flexible resource management
• Provide line management for direct reports, agree yearly objectives and give regular status updates.
• Recruitment, development, retention, and talent management of staff, including succession planning
• Ensure all work is performed in accordance with established procedures and internal and external requirements.
• Together with the Process Leads ensure process management activities are strategically aligned across the Regulatory area
• Collaborating with internal stakeholders to understand their requirements
• Identifying opportunities for process improvement, automation, or innovation within regulatory processes

Drive efficiency and quality in Process Management work

• Participate in AZ R&D activities to influence development Process Management Standards, Guidance and tools
• Drive a culture of continuous improvement, including adopting “Lean” type process improvement methodologies.
• Promote identification of underlying barriers to success
• Review and agrees high-level demand and supply and make recommendation for strategic changes, if needed.
• Partner with stakeholders within RTE, including Digital Strategy and Governance leaders to ensure process support for future (transformation) processes.

Process Lead:

• Accountable for the oversight, lifecycle management and strategic planning and development of nominated area and the Regulatory owned processes and procedural documents of their nominated area  and for ensuring compliance with applicable industry regulations and AstraZeneca Global and Local Policies. 
• Owns and is accountable for the long term stewardship of their nominated area  and for successful delivery of the business benefits.
• Fulfill all required responsibilities of BPO role as described in R&D Process Governance framework, when tasks delegated to Associate Directors/Manager/SMEs accountability for setting and communicating strategy and timelines remain.

Education, Qualifications, Skills and Experience:

Essential:

• Experience and understanding of the research and drug development life cycle and of the needs and ways of working of Regulatory Affairs 
• University Degree in Science or a related discipline 
• Strong leadership skills, including a demonstrated ability to manage stakeholders and influence the broader organization.   
• Passion for people development 
• 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  
• Excellent written and verbal communication skills in English
• Experience of working in a global organisation – across countries, cultures, and time zones. 
• Line manager experience
• Results Focused – ability to overcome obstacles and achieve key outcomes
• Cultural Awareness – able to work successfully in a multi-cultural environment
• Analytical Thinking - logically breaking situations or issues down into their essential elements; carrying out diagnosis and developing solutions.
• Ability to gain commitment – effectively uses interpersonal abilities to build relationships and gain acceptance of ideas
• Builds effective partnerships – identifies opportunities and takes actions to build effective relationships within team and with other areas

Desirable

• Experience as Business Process Owner (or BPAL) working with Procedural Document and BPM tools
• Knowledge of AZ business and processes. 
• In-depth regulatory knowledge and understanding of key regulatory activities and processes, Submission Excellence and Regulatory Operating Model  
• Facilitation skills 

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.