Regulatory Affairs Specialist

hace 4 días

Madrid Centro, Madrid, España Zentiva Group, a.s. A tiempo completo
About the Role

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 country level within our organization.

Key Responsibilities
  1. 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 Intelligence and Policy

Pro-actively review critical new legislation and guidance documents, share them with the central RA team, and disseminate to relevant parties information of importance to the business.

Relationship Building and Communication

Develop and build upon established relationships with the local Regulatory Authorities and other relevant organizations and personnel to facilitate activities required to meet the needs of the business.

Regulatory Submissions and Approvals

Plan and participate in the preparation of high-quality regulatory submissions to the authorities within agreed timeframes and according to agreed ways of working.

Compliance Monitoring and Inspection Readiness

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

Change Control and Labelling

Timely evaluate the impact of all Local, EU and Global outcomes on local labelling and manage change control for national procedures.

Collaboration and Communication

Cooperate with the Central team on evaluation, timely implementation, and change control for harmonised and centralized procedures in order to ensure compliance with given deadline corporate requirements.

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
  1. Education and Qualifications

Pharmacy Degree.

Language and Communication

English fluency.

Technical Skills

Good command with Microsoft-Windows tools.

Regulatory Knowledge and Experience

National / European legislation and internal regulation acquaintance.

Professional 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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