Senior Regulatory Affairs Executive BSc Science MSc Pharmaceutical MBA Broad based pharmaceutical background with experience in Data management, Pharmacovigilance, Quality, Clinical, Marketing and Regulatory areas. Extensive background in Regulatory affairs and most recent assigments involved the set up of Regulatory Affairs Departments for number of international generic manufacturers. Experience encompass the following: Regulatory Dossier formulation Strategy setting Opportunity and risk assessment The transfer of US files to Europe to facilitate European market submissions and support for US filing generation and maintenance. The implementation of good regulatory and quality working practices. Business and Regulatory strategy setting. Regulatory Compliance Inspections. The management of Registered details for compliance purposes and incorporation into the Quality Management System (QMS). The management of regulatory aspects of Clinical Trials, Food Supplements/US Dietary Supplements, Medicines and Medical Devices as required. The provision of technical support for R&D, Clinical, manufacturing and quality departments. For more information on our Panel of Interim Managers & Technical Experts plesae email info@pharmaexecutives.com or telephone + 353 (0)1 2800430 Interim Technical & Management Staffing Services   Why Interims The benefits of using Interim Executives and Technical Staff How Interim Staff Services Works Price Cost of hiring Interims Quality Panel  General management Operations Production Directors Managers Envirnomental Health Safety Reach Temporary Executives Research Development Technology Commercialisation Technology Transfer Sales marketing Business development Export International Sales and Marketing Logistics Purchasing Materials Planning Distribution Supply Chain Transportation Medical Device Engineers Staff Directors Managers Mechanical Electrical Maintenance Polymer Plastic Packaging Metal Precision Engineering Material Science Corporate Finance Banking Life Science Healthcare Sectors Regulatory Affairs Registration Register your Details to join our Executive Panel O'Loughlin Partnership Executive Search Selection Regulatory Training and Compliance Quality Consultancy Services Life Science Training Services Compliance and Regulatory Affairs meeting FDA IMB MRHA WHO Authorities Pharmaceutical and Medical Device Supply Chain Regulatory and Compliance Training Good Distribution Practice Cold Chain Temperature Controlled Logistics GDP Distribution Transportation Airports Ports Freight Forwarders Logistics Storage Wholesalers PharmaCareers is specialist division of the O'Loughlin Partnership engaged in assisting individuals with career advisory and training seeking a career move to the Life Science Industry Pharmaceutical Medical Device Biopharmaceuticals Diagnostics Healthcare