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Regulatory Affairs Specialist

hace 2 meses

Madrid, Madrid, España Zentiva Group, a.s. A tiempo completo

About Zentiva Group, a.s.

Zentiva Group, a.s. is a leading pharmaceutical company seeking a highly skilled Regulatory Affairs Specialist to join our team. As a Regulatory Affairs Specialist, you will play a critical role in ensuring the compliance of our products with EU and country-specific regulations.

Key Responsibilities:

  • Regulatory Compliance: Develop and maintain a comprehensive understanding of EU and country regulatory requirements, ensuring timely completion of all regulatory submissions and updates.
  • Regulatory Intelligence: Build relationships with local Regulatory Authorities and relevant organizations, participating in defining and implementing regulatory strategies.
  • Submission Preparation: Prepare high-quality regulatory submissions within agreed timeframes, monitoring submission progress and responding to regulatory authorities' deficiencies.
  • Product Registration: Update Marketing Authorizations in a timely manner, preparing and reviewing local mutations ensuring compliance with legislation.
  • Collaboration: Communicate effectively with supply chain and quality teams, highlighting compliance issues and proposing solutions.
  • Process Development: Contribute to writing and maintaining Standard Operating Procedures, scheduling and prioritizing team workload efficiently.
  • Support Functions: Support Market Access and Medical functions as needed, leveraging your expertise to drive business growth.

Requirements:

  • Education: Pharmacy Degree
  • Language: Fluency in English
  • Technical Skills: Proficiency in Microsoft-Windows tools
  • Regulatory Knowledge: Familiarity with National/European legislation and internal regulations
  • Experience: Over 10 years of similar experience
  • Personal Qualities: Demonstrated sense of ethics and responsibility, strong organizational and planning skills, effective communication and teamwork abilities, proactive and solution-focused mindset