My client, a global pharmaceutical company now have a new vacancy for a Regulatory Affairs Officer to join the growing Global Regulatory Affairs team located in Dublin.
Your role will be to prepare, contribute to and support their international registrations and Lifecycle activities for their current and actively growing range of pharmaceutical products.
• Acts as responsible Regulatory Team member for assigned regulatory projects
• Active member in a busy high quality globally focused regulatory team
• Preparation and submit Life-Cycle Maintenance regulatory submissions for EU and global markets
• Prepares and/or reviews regulatory documentation for submission to regulatory authorities.
• Actively participates and employs effective communication practices with internal customers (CMC, Supply Chain, Quality, Clinical, Medical, Pharmacovigilance and exglobal market Regulatory Managers).
• Maintain status reports for assigned projects
• Always perform assigned work according to current best good regulatory practice, SOPs and in compliance with current legislation and regulatory guidelines.
• Learn, develop and train
Qualifications & Experience required:
Degree in Pharmacy or life science-related degree plus at least 18 months relevant human pharmaceutical experience with focus on filing and lifecycle maintenance of marketed products in Europe and/or emerging markets
• >18 months’ 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)
• Familiarity of the CTD structure and content
• Experience of emerging markets / international RoW markets and regulatory filings
• 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 and or NEES
• Pharmaceutical artwork review experience
• Project management experience - an advantage
• Experience of Women’s and/or Men’s healthcare – an advantage