Regulatory Affairs Specialist
hace 3 días
Join Zentiva Group, A.S. as a Regulatory Affairs Specialist and take on a challenging role that requires a deep understanding of regulatory requirements and a proactive approach to ensuring compliance.
Key Responsibilities:- Manage the Regulatory Affairs agenda at country level, ensuring that all regulatory submissions are completed in a timely and efficient manner.
- Provide regulatory support to commercialization efforts, ensuring that products are launched in compliance with regulatory requirements.
- Ensure agility in daily interaction with authorities and competitive intelligence, staying up-to-date on new legislation and guidance documents.
- 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 local labeling compliance and inspection readiness, maintaining accurate and up-to-date regulatory documentation.
- Support other areas within Scientific Affairs, including Market Access, Medical, and Pharmacovigilance, as needed.
- Pharmacy degree and 10 years of similar experience.
- English fluency and good command of Microsoft-Windows tools.
- National and European legislation and internal regulation acquaintance.
- Sense of ethics and responsibility, sense of organization and planning, transversal cooperation, effective communication, proactivity, and focus on problem-solving.
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Regulatory Affairs Specialist
hace 1 semana
Madrid, Madrid, España Zentiva Group, a.s. A tiempo completoJob Title: Regulatory Affairs SpecialistAt 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...
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Madrid, Madrid, España Zentiva Group, a.s. A tiempo completoJob Title: Regulatory Affairs SpecialistAt 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...
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Madrid, Madrid, España Zentiva Group, a.s. A tiempo completoJob Title: Regulatory Affairs SpecialistZentiva 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 Zentiva.Key Responsibilities:Provide an efficient and proactive Regulatory...
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