Regulatory Affairs Specialist

hace 4 días

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

Zentiva Group, a.s. is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our Regulatory Affairs department, you will be responsible for managing the Regulatory Affairs agenda at the country level within Zentiva.

Key Responsibilities
  • Regulatory Strategy and Planning

Develop and maintain a comprehensive understanding and interpretation of EU and country regulatory requirements to enable regulatory submissions to be compiled in line with current requirements.

Regulatory Compliance

Ensure that Marketing Authorisations are updated in line with new safety information in a timely manner and compliance monitoring and inspection readiness.

Regulatory Documentation

Prepare and review local / local mutation of Summary of Product Characteristics, Package leaflets and text of packaging to ensure compliance with current legislation and registered particulars.

Communication and Collaboration

Communicate with supply chain and quality to ensure regulatory strategy is implemented within agreed time-frames to achieve an uninterrupted supply of compliant product to the market.

Administrative Tasks

Perform administrative tasks to ensure effective operation of the department and company, including updating of the regulatory database, monitor and implement department KPIs.

Requirements
  • Education

Pharmacy Degree

Language Skills

English fluency

Technical Skills

Good command with Microsoft-Windows tools

Experience

+10 years of similar experience

Personal Qualities

Sense of ethics and responsibility, sense of organization and planning, transversal cooperation, effective communication, proactivity, focus on problem solving

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