Oferta pracy

Regulatory Affairs Manager - EMEA


  • Migdałowa 4, Warszawa
    Warszawa, Masovian
  • offer expired 2 months ago
  • contract of employment
  • full-time
  • manager / supervisor
  • remote recruitment


Migdałowa 4


Your responsibilities

  • 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

Our requirements

  • 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

What we offer

  • 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"

  • Benefits

  • sharing the costs of sports activities

  • private medical care

  • sharing the costs of foreign language classes

  • sharing the costs of professional training & courses

  • life insurance

  • remote work opportunities

  • no dress code

  • extra social benefits

  • sharing the costs of tickets to the movies, theater

  • holiday funds

  • charity initiatives