Regulatory Affairs Professional, Data Integrity EMEA

The primary mission of the Process Support, Data Integrity & Compliance (PDC) team is to support the business in achieving and maintaining harmonized and compliant end-to-end processes, effective use of regulatory systems and tools, and robust tracking and management of regulatory data. Furthermore, the team provides support for audits, inspections and quality processes as required to maintain compliance across the regions.

• Update the regulatory tracking system (i.e. InSight) and/or the labeling information tracking system (i.e. LIFT) based on data entry requests received from Data Owners (e.g. EMEA Local Operating Companies (LOC), EMEA Regulatory Management Center (ERMC), EMEA Therapeutic Area Regulatory Scientists) for a variety of regulatory procedures, including but not limited to: Marketing Authorisation Applications/ License Renewals/Labeling variations/ Chemisty Manufacturing and Controls (CMC) variations/ License Withdrawals/Transfers/Expiries / Spontaneous Health Authority (HA) queries Aggregate report related HA queries
• Scrutinize data entry requests with Data Owners and instruct Data Onwers as needed, to ensure consistency and quality of data entered in InSight and LIFT.
• Follow-up with Data Owners to ensure completion of the assigned data entry request.
• Have a good understanding of all Regulatory procedures and the corresponding Internal Global Job Aids and Procedural documents to ensure that the requests are timely and accurately entered in the applicable regulatory systems.
• Collaborate effectively with the Data Owners and ensure data owner alignment with data entered on their behalf

• Minimum of a university degree or equivalent by experience.
• At least 2 years of Regulatory Affairs experience.
• Good understanding of Marketing Authorisation data and regulatory procedures (National as well as EU procedures).
• Understanding of Regulatory data planning and tracking requirements.
• Knowledge of compliance requirements and advanced process thinking.
• Ability to link legal and company internal requirements with regulatory process aspects and the applicable task management.
• Ability to work effectively in a matrix organisation with multiple cross-functional stakeholders on global, regional and local level.
• Excellent cross-cultural communication skills in English.

• Remote work from anywhere in Poland
• Employment via Manpower based on an employment contract
• Contract for a period of 9-12 months