Role DescriptionWe are looking for a Regulatory Affairs Data Verification Coordinator to coordinate and support data verification activities in our Marketing Authorisation data tracking system InSight. This role is critical to ensure the accuracy of EMEA data in InSight. The successful candidate should be able to effectively drive decisions and enforce actions in a process which is still developing, take appropriate EMEA decisions independently and escalate when needed.
Responsibilities- Coordinate verification of CMC baseline data and MA baseline data in InSight across EMEA Regulatory Affairs teams (Local Operating Companies LOCs and Therapeutic Areas TAs), under the oversight the EMEA RIM InSight Implementation Lead and in close collaboration with the EMEA InSight Data Entry Specialists - Liaise with the global RIM InSight team and CMC RA team on the data verification process, roles and responsibilities, to ensure alignment between global and EMEA expectations - Provide GRA EMEA LOCs and TAs with training, guidance and communication on the required verification activities - Support LOCs in verification activities as needed, including performing actual verification where appropriate and possible - Liaise with CMC RA to ensure EMEA verification feedback on CMC data is assessed and actioned - Liaise with EMEA Data Entry Specialists to ensure EMEA verification output is accurately entered/reflected in InSight.
Requirements- Good understanding of CTD Module 3 data - Understanding of local registration data tracking requirements - Knowledge of compliance requirements and advanced process thinking - Ability to work effectively in a matrix organisation with multiple cross-functional stakeholders on global, regional and local level
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Windimi Post.