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Employer: ManpowerGroup Solutions Sp. z o.o. We are seeking a candidate for the position of Regulatory Affairs Data Integrity Specialist located in Poland to support the global processes of our client. We are offering cooperation with one of the biggest pharmaceuticals concerns in Poland. This role will work in EMEA structure, in an international team.ZAKRES OBOWIĄZKÓW:
- Update the regulatory tracking system (InSight) and/or the labeling information tracking system (LIFT) based on data entry requests received from Data Owners such as EMEA Local Operating Companies, Regulatory Management Center, and Therapeutic Area Regulatory Scientists for various regulatory procedures
- Manage data entry related to Marketing Authorization Applications, License Renewals, Labeling Variations, CMC Variations, License Withdrawals, Transfers, Expiries, and Health Authority queries
- Scrutinize data entry requests with Data Owners to ensure consistency and accuracy of data entered in systems
- Follow up with Data Owners to ensure timely completion of data entry tasks
- Maintain a comprehensive understanding of all regulatory procedures and internal documentation to ensure accurate and prompt data entry
- Support Data Owners with guidance, training, and instructions on maintaining data in InSight and LIFT systems
- Assist team members with data integrity activities, onboarding new colleagues, and acting as a Subject Matter Expert
- Provide ad hoc reports and data support for audits, inspections, and quality investigations upon request
- Coordinate data verification activities and address queries with Data Owners
- Contribute to process development and improvement initiatives within EMEA and globally
WYMAGANIA:
- Minimum of a university degree or equivalent experience in a related field
- At least 2 years of professional experience in Regulatory Affairs
- Strong understanding of Marketing Authorization data and regulatory procedures at national and EU levels
- Knowledge of regulatory data planning and tracking requirements
- Ability to connect legal and internal company requirements with regulatory processes and task management
- Proficiency in technical skills relevant to data management systems
- Proven ability to monitor multiple actions and adhere to deadlines
- Capability to work independently and make informed decisions
- Excellent communication skills in English, with a proactive and collaborative approach
- Adaptability to evolving regulatory environments and requirements
OFERUJEMY:
- Employment via Manpower based on an employment contract
- Flexible work arrangement: remote (outside Warsaw) or hybrid (Warsaw-based)
- Manpower Premium employment benefits including healthcare coverage
- Additional perks such as a Sport Card to support a healthy lifestyle
- Opportunities for professional development and career growth within a global organization
- Supportive and inclusive work environment
- Seize this opportunity to become a vital part of a forward-thinking healthcare organization