Informacje o stanowisku

For our Client, one of the largest pharmaceutical companies in the world, we are looking for a Regulatory Affairs Specialist who will ensure compliance with regulations and interpretations of regulatory agencies.

The Regulatory Affairs Senior Specialist will be responsible for the operational submission management and delivery of regulatory submissions required to support product development, registration and compliance.

If you have relevant experience and you are ready for new professional challenges, apply for this role.

What we expect

• educational background (university degree in Life Sciences, Pharmacy etc.)
• professional experience in the pharmaceutical/ medical industry
• fluency in English
• strong understanding of the product development process
• ability to use regulatory information systems planning tools and/or publishing tools
• project management skills, problem solving and adaptability
• strong verbal and written communication skills
• team player

Employment agency entry number 47

this job offer is intended for people over 18 years of age

What we offer

• beneficial leave policies
• medical care program
• life insurance
• pension plan
• reimbursement of exercises
• cultural activitie

Your tasks

• management of product documentation packages in line with the regulatory strategy
• conducting a dossier review of published result
• conducting meetings of the application team
• monitoring the effectiveness of the dossier process
• participating in projects and initiatives to improve processes
• creates and signs specific documents
• using regulatory information management systems and tools to publish dossiers in accordance with regulatory requirements
• providing support to project team members
• tracking of ticket activities and schedules in appropriate systems

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