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 [email protected]
Thornshaw Scientific is a division of the CPL group www.thornshaw.com