Regulatory Affairs Specialist
hace 3 días
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 agenda at the country level, ensuring compliance with national and European regulations, and supporting the commercialization of products.
Key Responsibilities:- Provide proactive regulatory services to meet business objectives.
- Support the commercialization of products by ensuring regulatory compliance.
- 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 timely and complete 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 labeling compliance and inspection readiness.
- Secure the orderly and timely creation and maintenance of compliant regulatory documentation and labeling 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.
Support to Market Access (whenever applicable):
- Manage P&R requests to HA's for retail and hospital products;
- Manage price updates (such as increases, decreases, or price revisions by HA's);
- Support Annual Price revisions;
- Monitor legislation related to prices and ensure it fulfills national legislation;
Support to Medical:
- Support of upcoming launches;
- Responsible for Medical compliance elaboration, revision, and approval of educational materials, promotional and non-promotional materials and events, adherence to Industry Codes of Practice;
- Support to medical information function;
- To be in contact with external Key opinion leaders (when applicable);
- Support to the Ethical Compliance (transparency reporting);
Support to Pharmacovigilance (whenever applicable):
- Maintain routing of relevant web-links locally presented as a web of Side effects alerts;
- Literature screening;
- Support Periodic Reports (planning, local submissions);
- Ensure local support to Market Research;
Why Join Us:
At Zentiva Group, a.s., we offer a dynamic and challenging work environment that fosters growth and development. We are committed to excellence and innovation, and we are seeking talented individuals who share our values and passion for regulatory affairs.
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