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Manpower (Agencja zatrudnienia nr 412) to globalna firma o ponad 70-letnim doświadczeniu, działająca w 82 krajach. Na polskim rynku jesteśmy od 2001 roku i obecnie posiadamy prawie 35 oddziałów w całym kraju. Naszym celem jest otwieranie przed kandydatami nowych możliwości, pomoc w znalezieniu pracy odpowiadającej ich kwalifikacjom i doświadczeniu. Skontaktuj się z nami - to nic nie kosztuje, możesz za to zyskać profesjonalne doradztwo i wymarzoną pracę!Employer:ManpowerGroup Solutions Sp. z o.o.



Along with ManpowerGroup Solutions, we are seeking a candidate for the position ofRegulatory Affairs Data Entry/Data Integrity Specialistlocated 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 structrue, in an international team.



Tasks:

• 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
• Collaborate effectively with Data Owners to ensure alignment and data integrity
• 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
• Ensure data entry backup capabilities during team members’ vacations and holidays

Required skills and qualifications:

• 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
• Familiarity with compliance standards and advanced process thinking
• 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
• Effective in a matrix organization with cross-functional stakeholders at global, regional, and local levels
• Excellent communication skills in English, with a proactive and collaborative approach
• Adaptability to evolving regulatory environments and requirements

Offer:

• Competitive salary package aligned with industry standards
• Manpower Premium employment benefits
• Comprehensive healthcare coverage
• Sport Card to support an active lifestyle
• Life Insurance for additional security
• Training Package to support ongoing professional development
• Opportunity to work within a dynamic, innovative organization
• Clear pathways for career growth and advancement

Seize this opportunity to become a vital part of a reputable organization dedicated to advancing healthcare solutions. Apply now and contribute to meaningful projects that make a difference in patients lives. Join the team of our client and elevate your career in a stimulating and supportive environment.

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