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 offer- employment contract for 12 months
- hybrid work (2 days a week remote work)
- benefits package: medical care, multisport card, life insurance
- work in an international environment
- 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
- 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
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