Regulatory Affairs Specialist
hace 1 semana
At Zentiva Group, a.s., we are 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, ensuring compliance with national and European regulations.
Key Responsibilities:- Provide proactive Regulatory services to meet business objectives
- Support the commercialization of products
- Ensure agility in daily interactions with authorities and competitive intelligence
- Cooperate closely with Central RA in regulatory intelligence and policy areas, submission planning, and implementation of business excellence measures and business reporting
- Secure and timely completion of new regulatory approvals in national and European approval processes
- Ensure orderly and timely completion of all regulatory requirements to retain the registered product portfolio, its variations, and termination of approvals
- Ensure Local Labelling compliance and inspection readiness
- Secure the orderly and timely creation and maintenance of compliant regulatory documentation and labelling documents in line with agreed Ways of Working
- Support other areas within Scientific Affairs: Market Access, Medical, Pharmacovigilance (whenever applicable)
- Pharmacy Degree
- English fluency
- Good command of Microsoft-Windows tools
- National/European legislation and internal regulation acquaintance
- +10 years of similar experience
- Sense of ethics and responsibility
- Sense of organization and planning
- Transversal cooperation
- Effective communication
- Proactivity
- Focus on problem-solving
As a Regulatory Affairs Specialist at Zentiva Group, a.s., you will have the opportunity to work in a dynamic and challenging environment, contributing to the success of our company. If you are a motivated and experienced professional looking for a new challenge, we encourage you to apply for this exciting opportunity.
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