Life Science Research, Pharmaceutical
Poland
Posted 3 weeks ago
Regulatory and Artwork Coordinator (pharma) – Warsaw, Poland
Responsibilities:
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Support regulatory projects within the region and ensure regional input into global and cross-functional projects.
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Lead initiatives for continuous improvement of regulatory and artworks processes.
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Coordinate artworks tasks with internal and external stakeholders.
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Act as Local Super User for Regulatory Information Management System, providing support and training to local users.
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Organize access to Aspen systems and SharePoint for external consultants.
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Provide trainings on systems used, such as artwork system, to new team members.
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Assist in qualification of suppliers/service providers and management of power of attorneys.
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Process invoices of regulatory affairs/service providers and parallel import notifications.
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Assist in implementation of new deals and projects.
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Coordinate compiling of regulatory/artworks intelligence and periodic reporting to Head of RA (Europe).
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Work in multi-disciplinary team on projects, providing regulatory input.
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Ensure work is performed according to regulatory practice and compliance with legislation and guidelines.
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Implement Standard Operating Procedures relevant to regulatory function.
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Maintain accurate records and data management in line with Good Documentation Practice.
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Perform any other duties as assigned by Senior Management.
Requirements:
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Bachelor’s, Master’s, or Pharmacist degree in Life Sciences or related area.
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At least 2 years’ experience in Regulatory/Artwork Department in pharmaceutical industry in an international environment.
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Ability to work in complex matrix team environment with internal and external partners.
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Fluent in English and Polish
Benefits:
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Opportunity to work with a dynamic and innovative team.
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Exposure to international regulatory environments, fostering professional growth.
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Continuous learning and development opportunities.
