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Oferta pracy

Regulatory Affairs Manager - EMEA

BRENNTAG POLSKA Sp. z o.o.About the company

BRENNTAG POLSKA Sp. z o.o.

Migdałowa 4

Warszawa

Work within Pharma Services EMEA with main responsibilities in Central and Eastern Europe
Overall pharmacovigilance of imported APIs
Periodic review of changes in applicable legislation - update of documentation related to APIs, excipients and plant extracts in accordance with Polish and EU laws and regulations
Supervision over compliance of imported goods (API) with GMP requirements, licenses and documentation allowing Brenntag's customers to launch medicinal products on the market
Assistance and provision of documentation to suppliers and customers concerning
APIs, excipients and plant extracts offered and provide any other assistance
Perform tasks related to the maintenance of the GDP/GMP system, including contact with the Main Pharmaceutical Inspector
Liaising with suppliers and customers with regard to quality agreements
Participation in audits at customers, suppliers and manufacturers and preparation of audit reports
Cooperation with Pharma registration and quality departments
Participation in system validation processes related to transport and storage

University degree in pharmacy or chemistry
Knowledge of and experience in the field of GMP and GDP systems for APIs of at least 5 years
Very good, practical knowledge of Validation, GMP, GDP and ISO systems
Understanding Pharma legal regulations on APIs and excipients and Chief Sanitary Inspector’s regulations on plant extracts
Detailed knowledge of EU regulations on APIs and manufacturing steps for APIs and excipients
Extensive technical and operational expertise in the manufacture and documentation of APIs and excipients
In-depth knowledge of regulations, risks and practices concerning the import and placing on the market of APIs and excipients
Fluent Polish and English (both verbal and written)
Ability to handle multiple tasks to prioritize and schedule work to meet business needs
Flexible and analytical thinking to independently provide solutions to issues
Excellent interpersonal skills; ability to communicate, work in a diverse team environment and build relationships across a large organization

Work in a well-known, constantly growing international company, which is a leading distributor of chemicals
Opportunity to work in a professional team with real impact on business development in the CEE and EMEA region
Many possibilities to learn and exchange experiences with experts in the field
Attractive remuneration system with a package of additional benefits
Professional work tools
Opportunity to join the company-financed Employee Pension Plan "Brenntag PPE"