Regulatory Affairs Professional, Data Integrity

Role Overview

• 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], Cross-Regional Operations & Strategic Support teams (C-ROSS), EMEA Regulatory Affairs Therapeutic Areas) 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.
• Scrutinize data entry requests with Data Owners and instruct Data Owners 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.
• Maintain a good understanding of all Regulatory procedures and the corresponding Internal Global Job Aids and Procedural documents to ensure that requested data 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.
• Support Data Owners with guidance, training, instructions on the process and requirements for maintaining InSight and/or LIFT data.
• Support other team members in data integrity activities (e.g. onboard newcomers, act as Subject Matter Expert (SME)).
• Support GRA EMEA with ad hoc reports and data upon request, e.g. in relation to audits, inspections, quality investigations.
• Coordinate data verification activities and queries with Data Owners upon request.
• Contribute to process development and process improvement activities in EMEA and globally as needed (e.g. direct involvement into projects per expertise and career development interests).
• Align with team members to ensure data entry backup capabilities during vacation and holiday periods.

Requirements

• A 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).
• Experience with regulatory data planning, tracking (including regulatory data verification), remediation, and data quality support.
• Experience with EU XEVMPD and familiarity with the EMA Eudravigilance data environment.
• 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.
• Good technical skills.
• Proven ability to monitor multiple actions and timelines and follow up until completion.
• Experience in working with limited supervision and able to make independent decisions.
• 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.
• Proactive team-player, able to take charge and follow-through.
• Flexibility for limited travel when needed (≤5%)

Benefits

• an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions.
• vacation days
• parental leave for a minimum of 12 weeks
• bereavement leave
• caregiver leave
• volunteer leave
• well-being reimbursement
• programs for financial, physical and mental health
• service anniversary and recognition awards
• participation in several insurance plans (subject to the terms of their respective plans)