CSL Behring – the global biotherapies provider driven by its promise to save lives and to improve the quality of life for people with rare and serious medical conditions.
For our location in Bern, we are looking for a
The Lead of Global Regulatory Systems & Information Management has the key responsibilities to:
Translate the overall Global Regulatory Affairs (GRA) Business Process strategy into a detailed roadmap and architecture requirements for the Business Technology (BT) department
Unify regulatory systems and consolidate their data to reduce the likelihood of regulatory data quality issues, redundancy to achieve compliance
Main Responsibilities and Accountabilities:
Has overall responsibility (maintenance, configuration, improvement) for the GRA systems in scope: Regulatory Information Management System (RIMS), Systems to meet health authority requirements like xEVMPD and IDMP standards, Labeling tracking system, Document Management System, Archiving System, GRA SharePoints, repository and communication platform for Regulatory Policy and Intelligence as well as GRA intranet.
Has a leading role in global regulatory system related projects, including the implementation, maintenance/evolution of all GRA systems in scope for optimal support of the GRA business processes.
Ensures the assignment of one team member for each system in scope. This team member (Subject Matter Expert) will have full understanding of the system, both from a technical and regulatory process perspective, will be responsible for the validation, testing, implementation, maintenance, and issue resolving of the system and will support the users (including training) and GRA management (running metric data, reports etc).
Monitors regulatory information requirements and interfaces with regulatory bodies if needed, to ensure the implementation of new systems or the evolution of existing system to comply with these requirements.
Runs regulatory data quality and integrity assessment processes and perform data quality checks according various agreed dimensions.
Defines and implements in collaboration with regulatory Affairs process owners some system-based Key Performance Indicators and generates them on a regular basis.
Interfaces with GRA stakeholders, CSL Behring’s BT department for all system related matters (design of systems roadmap, implementation of new systems, vendor selection, system maintenance, issue resolving) and CSL Behring’s Enterprise Data Management department (CSL data governance and stewardship).
Actively participates in industry associations and vendor advisory boards to ensure CSL Behring GRA requirements regarding product developments are considered.
Supports the Head of GRA Operations and Business Excellence in developing the optimal infrastructure and working environment to support GRA as a whole in successfully delivering expected results.
Presents and informs senior management on GRA system related regulatory strategies and key issues
Manages the resources and budget from the team
Provides managerial oversight and leadership for the Global Regulatory Systems & Information Management Team.
Qualifications & Experience:
8 years of Pharmaceutical industry experience, ideally in a regulatory operations setting; 5 year experience with regulatory information management systems and processes.
Supervisory experience with teams both co-located and not co-located, in a matrix organization
Sound understanding and solid hands-on experience with regulatory information management and document management systems; experience with xEVMPD is a plus
Familiarity with at least EU and FDA regulatory information requirements, such as xEVMPD and IDMP standards
IT system implementation and maintenance experience
Good understanding of regulatory information management, both from a technical and regulatory process perspective
Experience with Data quality management processes
We are looking forward to receiving your online application. Applications must include a motivation letter and CV, as well as letters of references and copies of relevant transcripts and/or diplomas in the original language. Please include all these in one document together with the CV.
CSL Behring is committed to provide equal employment opportunity for all.
CSL Behring AG
Mr Patrick Plüss
Talent Acquisition Consultant
3000 Bern 22
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