Senior Regulatory Affairs Officer

My client, a global healthcare company now have a vacancy for a Senior Regulatory Affairs Officer.
Your role:
You will provide regulatory affairs support to support and manage International MAAs and Lifecycle activities for our current and actively growing range of pharmaceutical products, CAMs, our R&D pipeline products’ therapeutic indications and international markets.  
Responsibilities:
•    Acts as responsible Regulatory Team member for assigned regulatory projects (medicinal products, CAMs and ad hoc R&D pipeline) 
•    Preparation and filing of submissions including; life-cycle maintenance variations, initial MAA filling, labelling updates, renewals, obtaining CPPs, Marketing Authorisation Transfers (MATs) and publishing.  
•    Prepares and/or reviews regulatory documentation for DCP, MRP and National applications in line with assigned timelines.  
•    Support the strategic and operational planning and registration of CAMs in global markets 
•    Actively participates and employs effective communication practices with internal customers (CMC, CAMs team, Supply Chain, Quality, Legal, Clinical, Medical, Pharmacovigilance, globally based Regulatory Managers).  
•    Prepare status reports and metrics for assigned projects 
•    Perform assigned work according to current best good regulatory practice and in compliance with current legislation and regulatory guidelines at all times. 
•    Any other duties as assigned by your Manager 
•    Promote best regulatory practice and approach in business operations 
•    Promote and develop best use of regulatory tools and e-platforms  
•    Support Change Control and Quality Management process within GRA •     Any other duties as assigned on ad hoc basis      

Education and Experience:
•    >3 years pharmaceutical regulatory experience, focusing on lifecycle maintenance of marketed products in Europe and/or emerging markets (e.g. variations, renewals, new Marketing Authorisation Applications (MAAs) submissions)  
•    Experience of EU DCP and MRP MAAs  
•    Experience of emerging markets / international Row markets and regulatory filings is  
•    Quality control review of technical/ regulatory documents  
•    Understanding of Regulatory strategy and determination of documentation requirements Compliance with SOPs, Change controls and regulatory best practices  
•    Publishing: eCTD Office and or NEES – an advantage 
•    IT Literate and working familiarity with regulatory publishing platforms  
•    Project management experience  
Experience of CAMs/Food Supplements/Borderline/Nutritional products – advantageous

For full details contact Tina at +353 1 2784671 or email tdunne@thornshaw.com
Thornshaw Scientific is a division of the CPL group www.thornshaw.com