Regulatory Affairs Specialist
hace 1 mes
The Regulatory Affairs Specialist at Zentiva Group, a.s. is accountable for managing the Regulatory Affairs agenda at country level. This includes providing an efficient and proactive Regulatory service to meet business objectives, supporting commercialization of products, ensuring agility in daily interaction with authorities and competitive intelligence, and cooperating closely with Central RA in regulatory Intelligence and policy area.
Key Responsibilities:- Develop and maintain a comprehensive understanding and interpretation of EU and country regulatory requirements.
- Develop and build upon established relationships with local Regulatory Authorities and other relevant organizations.
- Participate in the definition and implementation of regulatory strategies and be proactively involved in the decision-making process.
- Plan and participate in the preparation of high-quality regulatory submissions to the authorities within agreed timeframes.
- Closely monitor the progress of submissions and participate in the efficient preparation and submission of responses to deficiencies noted by regulatory authorities.
- Ensure that Marketing Authorizations are updated in line with new safety information in a timely manner and compliance monitoring and inspection readiness.
- Prepare and review local/labelling version and communication in appropriate database.
- Communicate with supply chain and quality to ensure regulatory strategy is implemented within agreed time-frames to achieve an uninterrupted supply of compliant product to the market.
- Highlight compliance issues with all products within the portfolio and make proposals for their resolution.
- Perform administrative tasks to ensure effective operation of the department and company.
- 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 organization and planning.
- Transversal cooperation.
- Effective communication.
- Proactivity.
- Focus on problem solving.
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