We are currently recruiting for a Senior Regulatory Affairs Officer to join a rapidly growing Global Regulatory Affairs team located in Dublin. Your role will be to prepare, contribute to and manage MAAs and Lifecycle activities for current and actively growing range of pharmaceutical products, therapeutic indications and international markets.
Acts as responsible Regulatory Team member for assigned regulatory projects
- Preparation of 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 assigned 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.
- 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.
- Any other duties as assigned by your Manager
- MINIMUM REQUIRED EDUCATION AND EXPERIENCE
Degree in Pharmacy or life science-related degree plus at least 2 year’s relevant human pharmaceutical experience with focus on filing and lifecycle maintenance of marketed products in Europe and/or emerging markets
- 2-4 years 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)
- 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
For full details and confidential discussion please contact Linda at +353 1 2784671 or email your cv to email@example.com