Senior Regulatory Affairs Officer
- Experience Level
- Experienced (non-manager)
My client, a global pharmaceutical company with offices in Dublin City now have a new vacancy for a Senior Regulatory Affairs Officer.
Your role is to provide regulatory affairs support and manage International MAAs and Lifecycle activities for their current and actively growing range of pharmaceutical products, CAMs, R&D pipeline products’ therapeutic indications and international markets. Promote and facilitate team and corporate growth and success.
- Acts as responsible Regulatory Team member for assigned regulatory projects (medicinal products, 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).
- >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.
- Quality control review of technical/ regulatory documents
Understanding of Regulatory strategy and determination of documentation requirements
Full Job spec available on request.
For full details contact Ciara at email@example.com or call +353 1 2784671
Thornshaw Scientific Recruitment is a leading Irish Provider of Specialist Scientific Recruitment. Part of the CPL group. www.thornshaw.com