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Regulatory Affairs Officer Hungary & Poland

AVANTOR PERFORMANCE MATERIALS POLAND SA

  • Gdańsk

    Gdańsk, Pomeranian
  • offer expired 2 months ago
  • contract of employment
  • full-time
  • specialist (Mid / Regular)
  • home office work
  • remote recruitment

Your responsibilities

  • Analyze Hungarian, Polish & EU regulatory requirements and interpret regulatory acts, including changes, and ensure that they are communicated through the organization.

  • Draft and define, in cooperation with stakeholders, instructions with appropriate conformity actions for business.

  • Local Legal requirements / Legislation follow-up and update of Central team.

  • Contact with Hungarian & Polish authorities (participating on inspections, declarations & reporting, license requests).

  • Investigate queries with local authorities.

  • Accountable for obtaining, maintaining and renewal of local licenses to operate.

  • Provide customer guidance, monitor customer licenses and regulatory blocks.

  • Provide inputs for supplier’s product range introduction if local legislation to consider.

  • Support for central projects with local implementations.

  • Ensure that local organization is compliant with the Legal requirements/Legislation.

  • Suspect customers / transactions to raise to central RA team & authorities.

  • Check and approve license/EUD sent by customer and coordinates with central RA for unblocking.

  • Authority to block deliveries.

  • Communicate and up-date Central RA on all local activities (inspections, up-date in legislation, license requirements, ...).

  • Act/report proactively when recognizing significant business risks for Avantor.

  • Interact with local Departments (QA, Sales, Customer Services, Logistics, …) and with Central Departments (Central Regulatory, QA, Global Data Compliance, Sourcing, Product Management, Sales, …) as well as with customers and local authorities.

  • Develop or conduct employee regulatory trainings.

Our requirements

  • B.S. in applied science (Industrial Chemistry, Biomedical science, Biochemistry, Biotechnology) or other relevant degree.

  • 3 or more years’ experience in regulatory affairs in the European jurisdiction.

  • Comprehensive understanding of legal requirements.

  • Experience in Lab Supply Pharma / Chemicals or equivalent experience.

  • Proficiency in Microsoft Office tools and SAP (ERP).

  • Fluent in oral and written English, Polish.

  • Need an awareness of regulations / legislations with an interest in Regulatory Compliance topics.

  • Able to analyze, interpret regulatory requirements and define necessary solution driven actions.

  • Customer centric with advanced communication skills.

  • Open minded and team player in a multicultural environment.

  • Highly organized.

  • Adaptive, flexible, and change oriented.

  • Strong analytical and problem-solving skills.

  • Ability to support cross-functional teams.

  • Excellent time management skills with ability to prioritize tasks to meet tight deadlines.

  • Attentive to detail.

  • Knowledgeable about data analysis, and systems.

What we offer

  • We offer you a varied, full-time role in a dynamic international environment.

  • Participation in Avantor bonus program.

  • Employees’ benefits package: private healthcare, MultiSport card/MyBenefit cafeteria, social fund.

  • Flexible working arrangements.

  • Benefits

  • sharing the costs of sports activities

  • private medical care

Job summary

The Regulatory Affairs Officer Hungary & Poland will be responsible for legal tracking, vigilance, interpretation and, in cooperation with other business groups, concluding on necessary actions with regards to the new and updated legislation affecting our business.

Ensure that the business is correctly informed on the latest requirements and upcoming changes in the Polish, Hungarian & EU regulation.

The Local Regulatory Affairs Officer for Hungary & Poland will also support the Regulatory Affairs hub East (Czech Republic, Poland, Hungary).