Senior Manager, Regulatory Affairs

Regulatory Professionals
United Kingdom
27 Sep 2017
03 Nov 2017
Contract Type
Full Time
Senior Manager, Regulatory Affairs Buckinghamshire, UK Salary: up to £80,000 per annum plus competitive allowance and benefits package Job Reference: J30597 The company: A global pharmaceutical company with marketed products in over 80 countries worldwide are looking to recruit a Senior Regulatory Affairs Manager in their UK office. This pharma develops and manufactures a wide range of products and diagnostics in a range therapeutic areas. Main Responsibilities: * Provide regulatory expertise to development and global SOPs, including Paediatric development * Register and maintain pharmaceutical products * Maintain and lead Life Cycle Management of products * Maintain regulatory strategy, intelligence and risk assessments * Ensure compliance to European and other local regulatory requirements * Develop and maintain SOPs and WPs for Europe * Ensure processes are established through collaboration with other functional areas and partners Application Requirements: * Bachelor's degree in medicine, pharmacy, life sciences or chemistry * 7 years Regulatory Affairs experience * Life Cycle management experience for EU markets * Clinical development, MAA preparation and submissions experience * Experience with science advice meetings, PIPs and preclinical activities is desirable Alternatively, if you know someone that may be interested in this role then please feel free to pass this advertisement on and if they are successfully place then you'll receive £250 worth of vouchers of your choice. Buckinghamshire, Berkshire, Slough, Life Cycle Management, CTA, MAA, Centralised Procedure, LMC, Senior Manager, Regulatory Affairs