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Labelling Consultant - HertfordshireRef: BBBH24480

Salary:£40.00 - £50.00 per hour

Added:22 Nov 2019

Region: East Anglia

Sector: Pharmaceutical

Sub Sector: Regulatory Affairs

My client, a global Pharmaceutical company, is currently seeking a Regulatory Lead to join their team on an initial 12 month contract basis based in Hertfordshire. Responsibilities: *Authoring of the SmPC, confirming compliance with mandated safety triggers, Brand Leader, CMC and relevant Labelling requirements. *Authoring of the Package Leaflet (PL) and Labelling, ensuring consistency with the proposed, or approved, SmPC, relevant safety triggers and Labelling requirements. *Review of proposed, or approved, PI texts for compliance with relevant mandated safety triggers, Brand Leader (or other Legal Basis Reference Product) and CMC data. *Working with Global Product Safety and Risk Management - Safety Surveillance Team contact to ensure that the content of PI texts authored is verified and agreed with the Safety Surveillance Team. Where agreement cannot be reached, escalation of the issue to Labelling Committee for endorsement of recommendations. *Awareness of and adherence with Labelling requirements including, but not limited to, relevant internal and external legislation, regulations, standard operating procedures, guidance and templates etc. *As required, supporting Regulatory Leads with, but not limited to, responses to questions and requests for further information, which impact PI texts. *As required, other Labelling activities such Brand Leader monitoring to support the business. Experience Required: *Proficiency in speaking, comprehending, reading and writing English. *Knowledge of the regulatory pharmaceutical industry including labelling is desirable. *Life science degree is desirable. *BSc in Life sciences or related area. *At least 24-months Regulatory Affairs experience for Senior Registration Officer and at least 12 months Regulatory Affairs experience for Registration Officer. *Excellent prioritization and time-management skills. *IT literate with proficiency in using word, excel, power point. *Previous experience of Document Management System useful For further details, please contact Tim Barratt on +44(0)1727 817 626 or email tbarratt@keypeople.co.uk

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