Our client is a specialist pharmaceutical organisation focussed on the development and commercialisation of small molecule pharmaceuticals. Employing approximately 400 staff globally across 5 operations, this organisation is currently undergoing heavy expansion in both the U.S and EU as they are moving into the European markets with the success of product currently registered in the U.S. To facilitate this expansion they are seeking to recruit a Regulatory Affairs CMC Manager to be based at their operation in the midlands on a permanent basis.
Reporting to the Director for Regulatory Affairs you will be responsible for the following:
- Contributing to strategy development and technical writing for CMC regulatory submissions to support global regulatory and manufacturing activities with its investigational and marketed ophthalmic products, with a primary focus on the EU and secondarily the US
- Providing broader regulatory support to other submission types/other projects when necessary
- Managing the regulatory function and provide regulatory guidance in support of manufacturing activities onsite in the midlands
In order to be considered you must possess:
- A bachelors or advanced degree (MS, PhD or MD) in Life Sciences/Chemistry
- 8 years of European Regulatory Affairs experience in a pharmaceutical or biotechnology company
- Significant experience in a CMC Regulatory role
- Experience with steriles (desired)
- Experience of EU regulatory submissions
To discover more apply online or call Gillian McMurrough directly on +353 1 6321827 for a confidential discussion.