Regulatory Affairs Expert

hace 1 mes


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

Regulatory Affairs Specialist Role

The Regulatory Affairs Specialist at Zentiva Group, a.s. is accountable for managing the Regulatory Affairs agenda at country level within the company. This will include:

  • Providing an efficient and proactive Regulatory service to meet the business objectives
  • Supporting the commercialisation of products
  • Ensuring agility in daily interaction with authorities and competitive intelligence
  • Cooperating closely with Central RA in regulatory Intelligence and policy area, submission planning and implementation of business excellence measures and business reporting
  • Securing and timely complete new regulatory approvals in national and (if relevant) European approval processes
  • Ensuring Local Labelling compliance and inspection readiness
  • Securing the orderly and timely creation and maintenance of compliant regulatory documentation and labelling documents in line with agreed Ways of Working
  • Supporting other areas within Scientific Affairs: Market Access Medical Pharmacovigilance (whenever applicable)

Responsibilities

  • Developing and maintaining a comprehensive understanding and interpretation of EU and country regulatory requirements, to enable regulatory submissions to be compiled in line with current requirements
  • Developing and building upon established relationships with the local Regulatory Authorities and other relevant organisations and personnel
  • Participating on the definition and implement regulatory strategies and be proactively involved in the decision-making process
  • Planning and participating in the preparation of high quality regulatory submissions to the authorities within agreed timeframes
  • Closely monitoring the progress of submissions and participating on the efficient preparation and submission of responses to deficiencies noted by regulatory authorities
  • Informing relevant departments of deviations from regulatory schedules which may affect product supply
  • Ensuring that Marketing Authorisations are updated in line with new safety information in a timely manner and compliance monitoring and inspection readiness
  • Preparing and reviewing local/local mutation of Summary of Product Characteristics, Package leaflets and text of packaging to ensure compliance with current legislation and registered particulars
  • Archiving of all local labelling version and communication in appropriate database
  • Communicating with supply chain and quality to ensure regulatory strategy is implemented within agreed timeframes
  • Highlighting compliance issues with all products within the portfolio and making proposals for their resolution

Requirements

  • Pharmacy Degree
  • English fluency
  • Good command with Microsoft-Windows tools
  • National/European legislation and internal regulation acquaintance
  • +10 years of similar experience
  • Sense of ethics and responsibility
  • Sense of organisation and planning
  • Transversal cooperation
  • Effective communication
  • Proactivity
  • Focus on problem solving


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