Lead and coordinate business engagement in projects in collaboration with IT and Business Project Teams to ensure effective solution delivery and ongoing support
Collaborate with cross-functional teams (including Quality, IT, GRO, Regulatory Platform & Innovation Team) to optimize regulatory systems, ensuring they effectively support business objectives
Represent Regulatory Systems in cross-regulatory initiatives taking a lead role to define requirements, identify solutions, drive improvements, and ensure implementation
Provide operational support to GRA (Global Regulatory Affairs) for Regulatory Systems
Ownership and maintenance of the DTMS (Digital & Tech Management System) for our systems and tools
Manage and perform the User Acceptance Testing (UAT) process within the project lifecycle to ensure high-quality system performance
Proactively identify and mitigate risks associated with system usage and data management
Support audits and inspections by demonstrating compliance and providing accurate documentation related to assigned activities
Mentor junior staff within the team on processes and tools
Requirements
A Bachelor’s degree in a relevant field, such as Life Sciences, Pharmacy, Regulatory Affairs, Information Technology, or a related discipline, is required
Experience in managing/supporting regulatory business IT systems in a global environment
Deep understanding of a regulated environment, GxP, and quality standards
Manage and update DTMS documentation, Business System Owner responsibilities, and TPRM processes to ensure compliance and accuracy
Experience in Business Analysis and Business Process Design
Fluent communicator in English and the local language (Polish)
Good team player, with the confidence to lead when appropriate
Benefits
Hybrid work ( 2/3 days per week from the office)
Attractive reward package (annual bonus & awards for outstanding performance, recognition awards for additional achievements and engagement, holiday benefit)
Life insurance and pension plan
Private medical package with additional preventive healthcare services for employees and their eligible
Sports cards (Multisport)
Possibilities of development within the role and company’s structure
Personalized learning approach (internal trainings, mentoring, access to online training’ platforms: Keep Growing Campus, LinkedIn Learning, Business Skills, Harvard Manage Mentor, Skillsoft and external training)
Extensive support of work life balance (flexible working solutions, short Fridays option, health & well-being activities).
Supportive community and integration events
Modern office with creative rooms, fresh fruits every day
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