Regulatory Associate, Labelling

Regulatory Professionals
27 Sep 2017
03 Nov 2017
Contract Type
Full Time
Regulatory Associate, Labelling Wiltshire, UK Salary: Up to £35,0000, plus 25 days holiday, bonus, pension and healthcare Reference: J30673 Regulatory Professionals are working with an established international pharmaceutical company who are looking for a Regulatory Associate to manage all clinical labelling aspects of Regulatory Affairs. This client have a varied product range providing the opportunity to gain broad experience across multiple territories and have a structured growth plan that can provide clear development and progression. The company also value accountability and integrity throughout their endeavours in delivering healthcare products to patients. Main Responsibilities: * Management of clinical labelling aspects of Regulatory Affairs for a broad range of medicines * Review and coordinate CCDS, SmPC and labelling variations * Preparation, maintenance and further quality control of product information * Provide input for departmental QMS activities (may hold personal liability) * Liaise with EU competent authorities Application Requirements: * At least 2 years experience within Regulatory Affairs * Experience of reviewing CCDS is essential * EU Territory experience * Experience of labelling variations * Have written and reviewed SmPCs and PILs * Experience in dealing with EU Competent Authorities * Article 31 updates and PSUR experience highly desirable * Life Science degree * Ability to manage time effectively, multitask, prioritise and think strategically Wiltshire, Bristol, CCDS, labelling, clinical labelling, Regualtory, SmPCs, PILs, EU