Compliance Analyst supporting the approval and licensing of alcoholic beverages globally. Involves regulatory tasks, compliance reviews, and organizational duties in a dynamic environment.
About the role
- Senior Specialist in Regulatory Affairs handling licensing and compliance for pharmaceutical products. Collaborating with various departments to meet regulatory requirements and maintain standards.
Responsibilities
- Evaluate the technical documentation and prepare the technical dossier for different categories of products [i.e. CMC writing and Compilation of Common Technical Document (CTD) Module 3 and Module 2.3 (Quality Overall Summary), required for registration of new pharmaceutical products or variation & renewal applications for existing products], under minimum supervision
- Maintain current knowledge of relevant regulations, including proposed and final rules
- Implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained
- Ensure compliance with the company’s policies and procedures
- Ensure the maintenance of regulatory databases and departmental filing systems to facilitate accurate and retrievable records of department activities
- Work with specialist computer software and resources of the pharmaceutical products/raw material
- Communicate with all departments to ensure and provides properly and effectively any CMC regulatory support as required.
- Co-ordinate with R&D, Quality and Operations teams to ensure compliance to the relevant guidelines
Requirements
- BSc in a relevant area is required. Master of Science Degree (M.Sc.) is optional
- 3-5 years Regulatory Affairs experience in CMC RA Department of a pharmaceutical company
- Excellent Knowledge of the Greek & English language
- Computer literacy
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
Engagement Specialist managing client interactions at the Opportunity Center. Providing assessments and directing clients to appropriate resources for support.
Join a cross - functional team executing compliance reviews and managing motor vehicle record orders. Provide exceptional customer service and ensure data accuracy for consumer records.
Regional Compliance Manager overseeing compliance and performance in wraparound childcare services. Mentoring managers and ensuring Ofsted compliance across sites in Buckinghamshire, Northamptonshire, and Oxfordshire.
Client Onboarding & Compliance Specialist resolving client issues within a Payment Solutions company. Supporting customer onboarding and compliance for iGaming, eSports, and eCommerce sectors.
Senior Specialist managing regional regulatory projects and supporting compliance systems for healthcare company. Implementing digital strategy initiatives and collaborating with stakeholders through process improvement.
Leitung des Vertrags - und Versicherungsmanagements bei Klinikum Bayreuth. Verantwortung für Compliance und Schadensmanagement in einer spezialisierten Einrichtung der Maximalversorgung.
Manager Datenschutz & Compliance for Stadtwerke Potsdam GmbH maintaining data protection standards and compliance processes. Ensure transparency and auditable systems in data management across services.
Chargé de conformité environnementale & RGPD pour une entreprise digitale avec une forte Human Touch. Assurer la mise en conformité environnementale et de protection des données dans l'entreprise.
LA
Governance, Risk & Compliance Officer focusing on data protection in a renowned international trading company. Overseeing GRC structures and compliance with data protection regulations.