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About Zentiva Group, a.s.
Zentiva Group, a.s. is a leading pharmaceutical company seeking a highly skilled Regulatory Affairs Specialist to join our team. As a Regulatory Affairs Specialist, you will play a critical role in ensuring the company's compliance with EU regulatory requirements and managing the regulatory affairs agenda within the country.
Key Responsibilities:
- Regulatory Compliance: Develop and maintain a comprehensive understanding of EU and country regulatory requirements, ensuring timely completion of all regulatory requirements to retain the registered product portfolio.
- Regulatory Intelligence: Build relationships with local Regulatory Authorities and relevant organizations, participate in defining and implementing regulatory strategies, and prepare high-quality regulatory submissions within agreed timeframes.
- Regulatory Communication: Communicate effectively with supply chain and quality teams, highlight compliance issues, and propose solutions.
- Regulatory Documentation: Prepare and review local mutations ensuring compliance with legislation, update Marketing Authorizations in a timely manner, and contribute to writing and maintaining Standard Operating Procedures.
- Team Management: Schedule and prioritize team workload efficiently, support Market Access and Medical functions as needed, and contribute to the overall success of the Regulatory Affairs team.
Requirements:
- Education: Pharmacy Degree
- Language: Fluency in English
- Technical Skills: Proficiency in Microsoft-Windows tools
- Experience: Over 10 years of similar experience
- Personal Qualities: Demonstrated sense of ethics and responsibility, strong organizational and planning skills, effective communication and teamwork abilities, and a proactive and solution-focused mindset.
