About the Role:
Are you interested in working on the Regulatory Affairs Compliance team of a Generics Pharmaceutical company that is working on a global level? This company are currently the leading distributor of generic products in the Southern Hemisphere, and have a very large product portfolio. Based in an accessible location in Dublin, working in this company will give you experience working with a wide range of generic pharmaceutical products.
Day to Day:
As a valued senior member of the Regulatory Affairs team, you will:
- Ensure timely preparation and compilation of registration dossier for assigned projects in accordance to EU standards and corporate requirements
- Maintain assigned products' Marketing Authorisations via timely variations and renewals submissions and their approvals
- Build departmental awareness of local regulatory requirements in global markets
- Compile regulatory component of annual product review and PSUR
- Prepare the "master documentation" (containing all crucial correspondence and dossier up-dates required during registration procedure) to support all future post registration amendments and variations
- Review, prepare and compile the registration documentation required to maintain the assigned products' MAs, such as any variations (required by company or Regulatory Authorities), any supplements to dossiers, notification as well as renewals
- Review, give opinion (Re. registration requirements) and track the change control internal process
- BSc in a Life Science or Pharmacy
- 3-4 years' experience in a regulatory affairs environment
- Detailed knowledge of EU current registration requirements for dossier preparation and procedure running.
Working on the Regulatory Affairs team of this global Generics Pharmaceutical Company, you will be working with an extensive portfolio of products. The role is bases in Dublin in a fast paced and busy environment with huge learning prospects. The team has grown massively over the last 5 years with plans for further expansion. This is an opportunity to gain a wealth of knowledge and experience working with a large team on a global level.
For immediate consideration, please apply below with an up to date CV. Not sure yet? No CV ready? Give me a call for more information.
Sthree UK is acting as an Employment Agency in relation to this vacancy.