Description
I am currently searching for an experienced regulatory affairs labelling consultant for a contract role based in London.The role is 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, packaging text) for European Centralised Procedure and Mutual Recognition/Decentralised Procedure products throughout the product life-cycle.
- 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;
- 5 years in Regulatory or related area, 3 years 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, including pricing and reimbursement and promotion and advertising.
- Significant knowledge of global standards and regulations related to Marketing Authorisation Applications, Product Labelling, and the CCDS.
Please apply if you are interested. Alternatively, if you know anyone who may be interested please pass on these details. Any successful referral is entitled to £200 vouchers.
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