Informacje o stanowisku

For our Client, one of the largest pharmaceutical companies in the world, we are looking for a Regulatory Affairs Manager who will manage the operational delivery of regulatory documents for product registration and compliance. This person will manage the team and coordinate the plans for packages of documents sent.

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
• experience in team management
• ability to work or lead in a matrix environment and influence stakeholders
• knowledge of Regulatory Information Systems, planning, and publishing tools
• in-depth knowledge of project and submission management
• strong verbal and written communication skills

Employment agency entry number 47

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

What we offer

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

Your tasks

• coordinating the preparation and maintenance of regulatory submissions
• substantive support for project team members
• obtaining information from regulatory therapeutic areas, functional area representatives and key stakeholders
• management of dossier plans/submission packages in line with the regulatory strategy
• conducting a dossier review of published results
• ensuring that application activity is tracked and published using appropriate systems
• managing reporting team meetings
• being a leader in monitoring and effectiveness of the application process and initiating changes in decision-making authority
• applying appropriate regulatory reporting standards and practices to meet applicable health agency requirements
• developing departmental work practices and process improvements
• maintains relationships with key partners
• overseeing the performance and development of team members

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