Ermc Data Manager (Regulatory Affairs Specialist

**Position Summary**:The EMEA Regulatory Management Center (ERMC) is a regional Regulatory Affairs organization responsible for the majority of the operational regulatory maintenance activities, acting on behalf of EMEA Local Operating Companies (LOCs) and led by Senior Regulatory Staff. ERMC handles tactical Life Cycle Management (LCM) processes like CMC and Labeling variations in the region. ERMC is embedded in the EMEA RA regional organization and works in close collaboration with the respective LOCs, regional and global teams. ERMC is a virtual team reporting directly to the ERMC management and is located in the EMEA countries working mostly in the LOCs. This position is envisaged to support a large, diverse and complex geographic EMEA region. The responsibility of the ERMC Data Management is to cooperate with ERMC Lifecycle Management, ERMC Labeling Management, ERMC Planning, ERMC Compliance, other respective GRA stakeholders and LOCs respective RA staff on assigned CMC and Labeling variations, by performing specialized activities in the submission process for all countries within their cluster or even region. The ERMC Data Management has a direct reporting line to the ERMC Data Management sub-team Lead.**ERMC Data Management role**Data and record management (ensuring all assigned records in global systems and databases are filled-out and regional records are set up correctly and in time), including but not limited to:**InSight**:responsible for timely and accurate communication of impact assessment for assigned CMC variations using the applicable templates according to the type of procedure and submission as well as update throughout submission and approval process (as applicable); responsible for timely and accurate communication of actual submission and approval dates for assigned Labeling variations (as applicable); responsible for timely provision of information and approved PI for XEVMPD notification (EEA only).**LIFT**: responsible for timely impact assessment entry for assigned Labeling variations; timeline adjustments and extensions when applicable; set-up records for locally triggered changes as applicable.**SPS**: responsible for timely impact assessment entry for assigned CMC variations, update throughout submission and approval process and 2nd verification.**GRAIL**: responsible for archiving all relevant HA communications related to the assigned submissions.- Using the E2E Dashboard for better overview of actions for assigned Labeling variation records.- Following-up with link between InSight and LIFT in terms of data accuracy for variations in scope of ERMC.- Ensuring Compliance and Audit readiness within own tasks considering all applicable Procedural Documents, including participating in audit-readiness activities.- Contributing to implementation of new Systems and Processes applicable to Data Management activities to ensure efficiency gains and to support Business Continuity.- Participating actively in internal process improvements.- Communicating effectively with other ERMC sub-teams and Stakeholders.- Supporting other team members in Data Management activities.**WORKING RELATIONSHIPS/INTERFACES****With LOC**:- Local Regulatory Affairs staff, as needed, for country specific tracking in systems, align on procedures specific for data management activities, updates needed to license and marketing status in InSight.**Within ERMC**:- ERMC Planning as needed- ERMC Lifecycle Management on assigned NP, EU MRP, EU DCP submissions (throughout pre-submission to post-approval)- ERMC EUCP Coordinators on assigned EUCP submissions (throughout presubmission to post-approval)- ERMC Translation Management to obtain approved PI for XEVMPD purposes- ERMC Artwork Management on updating corresponding LIFT records and finding synergies- ERMC Data Management colleagues to align on processes and improve internal materials/processes, participate in common projects/SME roles, share best practices, back-up activities.- ERMC Compliance colleagues to align on compliance specific requirements and assure the appropriate evaluation and documentation**Within Global Regulatory Affairs**:- Global and Regional teams (e.g. EMEA Compliance & Business Support, GRA Q&C, Global Labeling CoE) to manage procedures and projects as applicable in specific areas.**Qualifications****Knowledge, Education, Experience, Communicatiob Skills REQUIREMENTS**:- A minimum of a University degree or equivalent by experience- At least 2 years of Regulatory Affairs experience- Proficiency in written and spoken English (including Business English)- Excellent verbal and written communication skills- Experience of working in a virtual team and/or global organization is an asset.- Experience in working with limited supervision and able to make independent decisions- Cultural sensitivity and ability to work and thrive in a multi-cultural environment.- Proactive team player, able to take charge and