Description
We are currently searching for 2 experienced regulatory affairs labelling consultants for a contract roles based in the south east.The roles are initially for 6 months (with the possibility of extension) and the hourly rate is £65-£75 depending on experience.
The Role;
- To support the development and maintenance of Product Labelling documents (SmPC, PIL and packaging text).
- Prepare the Company Core Datasheet (CCDS) for assigned compounds during the development/submission cycle, and maintains throughout the product lifecycle
- Analyse, interpret and communicate new external regulations and guidelines in Europe that have an impact on Product Labelling
Key Skills;
- Proven experience in Regulatory or related area and also experience in Labelling (or similar skill set) within the pharmaceutical industry.
- An expert understanding of European pharmaceutical regulation and guidelines/policies relating to Product Labelling.
- Significant knowledge of global standards and regulations related to Marketing Authorisation Applications, Product Labelling, and the CCDS.
Please apply if you are interested!
To find out more about Real please visit www.realstaffing.com
Real Staffing, a trading division of SThree Partnership LLP | Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales