Regulatory Reporting & Data Analyst
Based Reading, UK or Dublin, Ireland
About the Opportunity:
A new opportunity has arisen to join the Global Regulatory Affairs (GRA) Reporting & Analytics team and be responsible for reporting and analytics activities for Global Regulatory Affairs.
This group works to ensure that GRA has access to state-of-the-art reporting solutions and supports providing reports and analysis needs for the department, including inspections, audits and general business needs.
GRA Reports and reporting solutions are critical to support inspections by Regulatory Authorities, and audits, Regulatory decisions and activities, information provided to Health Authorities, and for compliance with global regulatory requirements, to help the responsible group verify Key Performance Indicators (KPI), for the user community to self-check their compliance with KPIs.
GRA provides services globally to all R&D units and to all Sanofi affiliates (fully connected sites plus all countries with industrial and/or commercial operations). The Reports team primarily supports GRA but can also provide reports and analytics on Regulatory data needed for other areas of Sanofi.
· Be the primary point of contact for EU inspections & audits. Corporates with US colleagues for US inspections & audits if the requests need to be done at EU time zone.
· Provides vision and strategy for the GRA reporting and analytics framework.
· Be the primary point of contact for GRA Reporting and Analytics information needs.
· Collaborates with the GRA Data Management and Data QC functions to ensure information provided is of highest quality.
· Collaborates with the GRO Business Process Excellence, ITS and other functions to develop the GRA Reporting and Analytics technical solutions that are aligned with the vision and strategy.
· Analyse requirements and specifications for information, reports and analytics with a solid understanding of Regulatory business data, system data models, and technical skills.
· Ensures that report and analytics designs providing the quality information needed by Regulatory for decision making, health and safety reporting, and other organizational activities.
· Prepares information, reports, extracts and analytics for Regulatory Organization and Leadership, and for internal audits and inspections by Regulatory Agencies.
Group’s primary areas of responsibility include:
· Functions as the primary owner and point of contact for GRA for reporting and analytics capabilities and activities.
· Ensures that the formal reporting and analytic process and methodology is defined, implemented and followed to ensure quality deliverables and to meet the needs of the user community.
· Provides the vision and strategy for Reporting and Analytics.
· Leads the development of GRA business requirements for Reporting and Analytics target solutions.
· Collaborates with ITS to provide the reporting and analytic solutions.
· Leads or supports Reporting and Analytics related projects for Systems Implementation Projects.
· Ensures highest quality information provided to customers in an efficient way.
To excel in this role, you will need to have:
· BS degree in math, science or engineering with 5+ years’ experience in pharmaceutical industry.
· Strong knowledge of Regulatory Affairs/Operations domain and regulatory requirements.
· Strong knowledge of SQL or SAS, Python.
· Strong knowledge of Microsoft Excel, VBA is a plus.
· High degree of technical knowledge, reporting capability development, testing, validation, query and report performance enhancing strategies are strongly desired.
· Strong Veeva VAULT RIM and Business Objects Universe design, creation, testing and technical skills are desired.
· Strong understanding of the different domains within Regulatory Affairs including Data Management, Labelling, Document Management and reporting needs.
· Working knowledge of regulatory requirements in multiple jurisdictions, specifically as they pertain to Registration Tracking.
· Ability to lead multi-disciplinary teams and interface with upper level management of support and client organizations.
· Strong interpersonal skills to be effective in the leadership of global teams.
· Language: English to work in an international context.
· Ability to travel at minimum level.
Knowledge and Skills desirable but not essential
· 5 years’ experience in ITS technical support.
· ITS skills: technical and database background.
· Experience on Regulatory systems”; “end-user support”.
· Basic knowledge of GxP, Good Pharmacovigilance Practices.
What Sanofi can offer you:
· A role where you are instrumental to creating best practice and as the organisation grows, you can too.
· We offer a generous package including flexible benefits and are committed to helping you have a healthy work-life balance throughout your career with us.
· This is a full-time role and we support flexible working.
Empower Life Everyday
At Sanofi we work across human health from vaccines to rare diseases, and consumer healthcare. This creates opportunities to work across different areas to build a diverse and exciting career. Sanofi has the capabilities and resources to support your aspirations to fulfil your ambitions and be the best you can be.
Our purpose at Sanofi is to work passionately every day to understand and solve healthcare needs of people across the world. Our ambition is by 2025, to be a top 3 innovative, global and diversified human healthcare company. One that embraces transformative technologies and is focused on its area of excellence, which means we’re not there to try to solve everybody’s problems. We want to focus on those areas where we know we are making a difference.
The values we are live by are teamwork, courage, respect and integrity.
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.