Regulatory Affairs Manager
- Experience Level
We are now recruiting for a Regulatory Affairs Manager for our client to join a rapidly growing Global Regulatory Affairs team located in Dublin city. The Dublin team provide regulatory operations and strategy support to their current and growing product portfolio, therapy areas and international market presence.
• Acts as responsible Senior Regulatory Team member for assigned regulatory projects
• Preparation and responsibility for regulatory submissions including Marketing Authorization Transfer, CMC variation filling, initial MAA filling, labelling updates, renewals, CMC authoring and \ or updates as required.
• Prepares and/or reviews regulatory documentation for DCP, MRP and National applications in line with Corporate needs and timelines.
• Actively participates and employs effective communication practices with internal customers (CMC, Supply Chain, Quality, Legal, Clinical, Pharmacovigilance, Regional Regulatory Managers, Regional Heads).
• Understands the Scope of Work, timelines and deliverables for a given project.
• Manage Regulatory Projects and /or regulatory team members
• Prepare status reports and metrics for assigned projects
• Perform assigned work according to current best regulatory practice and in compliance with current legislation and regulatory guidelines.
• Promote best regulatory practice and approach in business operations
• Promote and develop best use of regulatory tools and e-platforms
• Any other duties as assigned by your Manager
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
Degree in Pharmacy or life science-related degree plus at least 6 year’s relevant human pharmaceutical experience with focus on filing and lifecycle maintenance of marketed products in Europe and/or emerging markets
• Writing and preparation of relevant CTD (Common Technical Dossier) documents to support submissions, in collaboration with Technical/CMC/Clinical/Labelling experts
• Experience of EU DCP and MRP MAAs
• 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, timelines, budgets and filing options
• Compliance with SOPs, Change controls and regulatory best practices
• Pharmaceutical artwork review and sign-off
• Project management experience - an advantage
• Experience of Women’s and/or Men’s healthcare – an advantage
• Experience of US Regulatory Affairs – an advantage
• Experience of Medical Devices – an advantage
For full details and confidential discussion please contact Tina at +353 1 2784671 or email your cv to email@example.com