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Regulatory Affairs Specialist
Company description
For our client, a global leader in the pharmaceutical industry, we are looking for a Regulatory Affairs Specialist.
Description
Ensuring regulatory strategies align with business priorities, executing product submissions, and maintaining marketing authorizations;
Monitoring, assessing, and sharing updates on new regulatory requirements and best practices;
Compiling, maintaining, and archiving regulatory documents, including managing translation activities and updating databases;
Adhering to internal compliance rules, contributing to CAPA processes, supporting audit programs, and ensuring local inspection readiness;
Acting as a point of contact for clinical trial activities, providing input on regulatory issues, and contributing to operational excellence;
Engaging with internal departments, participating in business forums, and contributing to cross-functional regulatory activities;
Fostering a culture of innovation, promoting best practices, and seeking opportunities for process simplification and operational efficiency.
Requirements
University degree in a scientific field (Pharmacy, Medicine, Biology);
Minimum of 2-3 years of relevant experience in Regulatory Affairs within an international pharmaceutical company (excluding CROs);
Experience with various authorization procedures, including the centralized procedure (CP), MRP/DCP, and national procedures;
Proficiency in technical systems (MS Office applications, databases—Veeva is a plus, online research);
Strong command of English;
Excellent organizational, communication, and problem-solving skills, with a proactive attitude, attention to detail, and the ability to manage multiple projects and deadlines effectively.
