Regulatory Affairs Expert
hace 1 mes
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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