Hybrid Manager, Regulatory Operations

Posted last month

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About the role

  • 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

Job title

Manager, Regulatory Operations

Job type

Experience level

Mid levelSenior

Salary

Not specified

Degree requirement

Bachelor's Degree

Location requirements

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