Support product registrations, provide design input and assess changes to ensure regulatory product availability on global markets as per In-Center commercial strategy.
Tasks
* Obtain and sustain global registrations for In-Center product portfolio as per Regulatory Strategy and product roadmap.
* Compile Global Registration File per product and customise/supplement in preparation of local submission where necessary.
* Communicate/collaborate with relevant interfaces e.g., In-Center Product Centers and Value Streams, SYSQARA Regulatory Affairs and Registration Centers of Verticals Home and CC&V.
* Perform site registrations.
* Provide regulatory design input as per available information from SYSQARA functions as well as submission strategy guidance to sustaining and development project teams in In-Center Value Streams to ensure creation of approval-relevant documents.
* Determine and maintain relevant criteria and on that basis assess design and process changes, initiate local evaluation of potential regulatory impact as appropriate, monitor local feedback.
* Support global agency audits e.g., by FDA, NMPA, INMETRO and audits by Notified Body.
* Initiate production transfer after registration approval.
* Perform tasks relevant to the Quality Management System e.g., CAPA.
* Prepare regulatory documentation required for tender procedures.
Requirements
Completed studies in a scientific/technical field or comparable training with professional experience.
Minimum 1 year of professional experience in the field of Regulatory Affairs, Quality Management or other related Research and Development functions.
Languages
* English, written and oral, preferably competence level C1-2, minimum B2.
* German optional.
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