Director, UK & Ireland Regualtory Affairs & Quality

This is what you will do:

This position is responsible for development and implementation of the UK and Ireland regulatory strategy and activities plus quality activities for all Alexion portfolio products . The Director, UK & Ireland Regulatory Affairs and Quality will ensure full compliance with all local regulations and corporate policies and act as the main contact person accountable for regulatory and quality activities in the UK and Ireland marketing company, in respect to regulatory authorities. This individual will be responsible for overseeing the implementation and execution of the Corporate Quality System at the designated affiliate(s) within Alexion. Will act as a Local Regulator or Quality lead as necessary according to the needs of the team.

You will be responsible for:

Regulaltory Affairs and Quality Team Leadership

• Lead and manage the Regualtory Affairs & Quality team to ensure achievement of objectives, personal development, and ensuring the team is trained and equipped to achieve established goals. Responsible for recruitment, performance management, development and succession planning across the team. 

• Lead regulatory and quality team members  to deliver on local responsibilities outlined in regulations, policies, and internal standards, aligned with business priorities.Ensure alignment of local regulatory & quality objectives with global regulatory and quality plans
• Ensure the local Regulatory Affairs & Quality team are appropriately resourced, directed and support the local franchise teams and collaborate with other functions
• Lead organisational change efforts impacting local Regulatory & Quality Affairs team
• Ensure Regualtory Affairs & Quality team maintain compliance with ABPI Code of Practice, relevant laws and Alexion policies and procedure
• Routinely assess, maximise and communicate the performance of the Regulatory Affairs & Quality team locally and globally as relevant.
• Good understanding of UK regulatory pathways including International Recognition route (IRP), Innovative Licencing and Access Pathway (ILAP), Promising Innovative Medicine (PIM) and Early Access to Medicine (EAMs) scheme.
  

Regulatory Affairs and Quality Thought Ledership

• Develop  country affiliate regulatory strategy aligned with UK/IE market access strategy and, input to regulatory strategies for pipeline products
• Manage regulatory strategies for  approved products in terms of life cycle management and commercial quality aspects.
• In collaboration with global regulatory leads (GRL) and UK cross functional stakeholders, advise on clinical trial strategy where needed, and possible national scientific advice if relevant.
• Partner and coordinate with Commercial, Medical Affairs, Market Access, Business Operations and Management (such as BUL, Medical Director, GM etc.) to define regulatory and quality priorities based on business opportunities and the affiliate’s business objectives.
• Provide input into the development and implementation of successful asset commercialistion plans including market-access strategies, where required.
• Provides local regulatory environment intelligence and advises on expected regulatory hurdles and solutions relevant to UK/IE specificities, while actively shaping the local regulatory environment for optimal outcomes.
• Oversee local regulatory submissions in coordination with other Global Regulatory and Quality functions.
• Oversee roll out and ongoing compliance to Alexion’s Global Quality and Compliance systems and associated procedures and standards.
• Assure appropriate escalations and notification to line management.
• Ensure that Alexion Policies, Global Quality Standards Operating Procedures (SOPs) are implemented in accordance with global and local GxP requirements
• Monitor GxP compliance to regulations and Alexion’s procedures and communicate CAPAs and action plans to Country Management and Corporate Quality Partner with local, regional, and global operational groups to foster a proactive approach to quality and compliance.
• Provide Quality leadership for territory expansion and new product introductions locally. This includes the maintenance and necessary updates to QAGs (Quality Agreements), initiation of audits, and support of required Quality documentation
  

Key contact with local health authorities and inspectors

• Develop relationships and facilitate early engagament with relevant MHRA stakeholders
• Accountable for all interactions with local Health authorities, including health authority meetings, inspections, and other regulatory compliance aspects.
• Responsible for local review, implementation and tracking of implementation of the risk management plans (RMP) and other post-authorization aspects for the Alexion products.
• Oversee the review and implementation of Quality Improvement/remediation plans locally.
• Ensure adherence to Alexion procedures to vendor oversight, periodic KPI review and appropriate risk assessment and mitigation

You will need to have:

• Bachelor’s degree, preferably in life sciences.

• 10 years of hands-on Regulatory and/or Quality Assurance / Compliance and management experience in pharmaceutical/ biotech industry.
• Thorough knowledge of applicable local and global regulatory requirements required for GXP compliance.
• Extensive knowledge in a broad range of pharmaceutical regulatory activities and Quality Systems.
• Strong Management & leadership ability
• Exceptional communication and interpersonal skills
• Ability to work globally in a matrix environment
• Ability to influence senior management, peers, and other colleagues without direct reporting lines
• Ability to work in a dynamic environment and to constantly redefine the scope of responsibilities in alignment with compliance and business needs
• Fluent English language skills
• The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.

We would prefer for you to have:

• Advanced degree (PharmD or PhD)

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.