RA Specialist CMC
Our client, a global healthcare organisation is seeking an experienced Regulatory Affairs Specialist (CMC) to join their expanding team in Dublin. At least 3 years’ working experience within CMC development/LCM of approved products is an absolute necessity.
Reporting into the Global CMC Manager, you will:
- Work with life-cycle management of the quality documentation for approved drug products and drug substances
- Obtain approvals in new markets and support renewal applications
- Work cross functionally participating in preparation of quality documentation for various submission
- 3 years’+ Regulatory Affairs experience within CMC development or life-cycle management (LCM) of approved products
- Current knowledge of regulatory requirements within EU including markets outside EU
To discover more about the role, apply online or contact Sorcha Hayward at HRM directly on +353 1 6321866 for a confidential discussion.
Salary: €50000 - €55000
Location: Dublin South