Informacje o stanowisku

Currently, for our client, an international company from the pharmaceutical industry, we are looking for a person to join the international Regulatory Affairs Team.

What we expect

• experience in a similar position in the pharmaceutical or cosmetics industry
• higher education
• Fluent knowledge of English and Polish (level C1/C2)
• good understanding of pharmaceutical Marketing Authorisation data and regulatory procedures (national as well as EU procedures)
• understanding of regulatory data planning and tracking requirements
• knowledge of compliance requirements and advanced process thinking
• proven ability to monitor multiple actions and timelines and follow up until timely completion
• ability to work effectively in a matrix organisation with multiple cross-functional stakeholders on global, regional and local level

Employment agency entry number 47

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

What we offer

• employment contract for 12 months with the possibility of extension
• hybrid work (2 days a week remote work)
• benefits package: medical care, multisport card, life insurance
• work in an international environment

Your tasks

• regulatory Affairs data entry activities
• track incoming data entry requests and follow up until completion in alignment with global and regional data quality standards and procedures
• enter data in the relevant systems based on information provided by data owners
• scrutinize provided data with data owners and instruct data owners as needed, to ensure consistency and quality of data in the relevant systems
• ensure data owner alignment with data entered in the relevant systesms on their behalf
• support data owners with guidance, training, instructions on the process and requirements for maintaining data in the relevant systems
• provide ad hoc reports and data upon request, e.g. in relation to audits, inspections, quality investigations
• coordinate and/or perform other data management acitivites upon request
• contribute to process development and process improvement activities in EMEA and globally as needed

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