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Labelling LeadRef: 24483

Salary:£25.00 - £35.00 per hour

Added:02 Dec 2019

Region: East Anglia

Sector: Pharmaceutical

Sub Sector: Regulatory Affairs

My client located in Hertfordshire is looking for a Labelling Lead on a 12 month contract.This will involve but not be restricted to Authoring of the SmPC, confirming compliance with mandated safety triggers, Brand Leader, CMC and relevant Labelling requirements. Responsibilities: *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. *Collaborating with Global Product Safety and Risk Management - Safety Surveillance Team contact to make sure 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 restricted to, appropriate internal and external legislation, regulations, standard operating procedures, guidance and templates etc. *As required, supporting Regulatory Leads with, but not restricted to, responses to questions and requests for further information, which affect PI texts. *As required, other Labelling activities such Brand Leader monitoring to support the business. Candidate Profile: *Proficiency in speaking, understanding, reading and writing English. *Fantastic prioritization and time-management skills. *Good verbal and written communication skills. *IT literate with proficiency in using word, excel, power point. *Office acumen, good team player, multitasker, business focused. *Good understanding of the regulatory pharmaceutical industry including labelling is desirable. *Life science degree is preferable. * BSc in Life sciences or similar area. At least 24-months Regulatory Affairs experience for Senior Registration Officer and at least 12 months Regulatory Affairs experience for Registration Officer. *Proficiency in speaking, comprehending, reading and writing English. *Excellent prioritization and time-management skills. *IT literate with proficiency in using word, excel, power point. *Previous exposure to Document Management System is ideal If the role outlined above is of interest or you feel it suits your experience, please apply and feel free to get in touch with Ross Wilson at rwilson@keypeople.co.uk or on +44(0)1727 817621 for further details.

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