Lead Regulation Intelligence Network (RIN)

Job content

Lead Regulation Intelligence Network (RIN)

To strengthen our Global Quality Assurance organization, we are looking to fill the position of: Lead Regulation Intelligence Network (RIN).

This role can be located in Belgium, Germany, Switzerland or United Kindgom.

As a Lead Regulation Intelligence Network (RIN), you like to work in an environment where you can:

• Be accountable to design and manage a well-functioning and effective RIN process, including supporting technology/tool, to keep abreast with GXP Regulation updates, from the Regulation Landscape all the way through Enforcement Analytics, in alignment with ICH Q10, to ultimately secure Compliance and business Continuity.
• Drive and empower a Network of Stakeholders & Experts across the Enterprise to monitor, assess, and implement Regulation updates.
• Represent UCB as a company in industry association(s) to articulate UCB’s interest and advocate UCB’s Quality mindset when industry positions are formulated in this group.

As a Lead Regulation Intelligence Network (RIN), you will contribute by:

RIN ‘Business Process Owner’ (BPO)/’Corporate Process Owner’ (GxP CPO):

• Define the RIN Strategy and Improvement Plan.
• Identify, train, mentor and maintain a Community of Global RIN Leaders across GXP areas to monitor Regulation updates for their area and drive all associated RIN activities.
• Power a Network of Experts across departments and geographies to assess and implement Regulation updates. Closely collaborate with functional leaders in Quality and Business (Development Solutions, S&TS, Early Solutions) to identify and assign functional RIN Leads and SMEs in business units.
• Collaborate with the QMS Leads in Quality and functional QMS Leads to secure that the changes/improvements triggered by Regulation updates are embedded into the Quality Systems/Business Processes as appropriate.
• Establish appropriate RIN Governance to drive decision-making, using a risk-based approach.
• Lead the RIN Governance Body and closely work with the senior leaders to prioritize risk mitigating measures and to identify emerging new regulations which require escalation to Senior Management
• Present risks from emerging new regulations and mitigation measures identified at RIN Governance Body at DMSO and other senior management governing bodies for decision making
• Drive RIN Digital Transformation to improve Engagement & Performance of the RIN Process.
• Leverage external engagement & participate to the advocacy effort.
• Develop and Execute a RIN communication plan for key stakeholders.
• Establish dashboards & metrics to oversee RIN activities and monitor Engagement, Performance and Compliance of the RIN Process.
• Present RIN Metrics and compliance of the RIN Process to QA Leadership Team as appropriate

RIN ‘Process Data Owner’ (PDO) for the RIN Tool:

• Design and maintain the RIN tool and associated data to cover RIN scope and meet User requirements.
• Lead RIN Tool related projects as QA project lead. Lead and facilitate respective core team and/or steering committee meetings.
• Define access governance and related Training strategy.
• Drive continuous improvement of the RIN tool based upon advances in technology and feedback from key stakeholders and user community.

UCB representative on EFPIA MQEG:

• Represent UCB as a company in EFPIA industry association on the Manufacturing, Quality & Environment Group (MQEG)
• Articulate UCB’s interest and advocate UCB’s Quality mindset when industry positions are formulated in the MQEG group
• Orchestrate within UCB review and commenting through SME network and consolidate comments to be shared with MQEG where EFPIA builds a consolidated biopharma industry response to regulatory bodies on new emerging draft regulations or concept papers
• Actively benchmark within MQEG network on particular topics important for UCB and present benchmark results to UCB leadership teams as appropriate

Interested? For this position you’ll need the following education, experience and skills:

• Master’s degree related to the field of activity
• 8-10 years working in a pharmaceutical company or equivalent
• Minimum 5 years working in quality assurance with exposure to regulations (ICH, GxP, Compliance)
• Preferred experience with ICH Q10 Quality Systems or equivalent
• Strategic Thinking
• Positive Leadership and ability to lead in a complex Matrix
• Strong organizational skills
• Strong interpersonal skills to make connections and foster collaboration
• Ability to present complex topics with confidence to senior leaders
• Self-confidence and standing to represent UCB at industry associations
• Change Management skills
• Project Management skills
• Problem solving skills using a risk-based approach
• Digital Literacy
• Technical writing skills
• Educational & Training skills
• Fluent in English, French is an asset