Senior Manager Regulatory Affairs

Regulatory Professionals
United Kingdom
27 Sep 2017
03 Nov 2017
Contract Type
Full Time
Senior Manager Regulatory Affairs Competitive Salary + Benefits Location: Slough Reference: J30646 Our client, a global pharmaceutical company, has been thriving in the industry for over 90 years discovering and developing treatments for central nervous system disorders, cardiovascular, cancer and respiratory disorders accompanied with a range of clinical, nutritional and diagnostic products. They are seeking a candidate with experience in global regulatory affairs surrounding strategic and operational aspects as well as experience working in and communicating with cross functional and multi-cultural project teams. Responsibilities will include: * Providing regulatory expertise to development and internal global SOPs including Paediatric development, registration and maintenance of pharmaceutical products with assigned projects * Acting as the primary contact to Competent Authorities for assigned projects and responsibilities * Guaranteeing that regulatory activities are performed to the highest quality and compliant to all local regulatory requirements * Developing and maintaining regulatory strategy, with a focus on European regulatory procedures and requirements when dealing with regulatory intelligence and regulatory risk assessments * Ensuring a constant awareness of support and compliance to the EU and other local regulatory requirements * Developing and maintaining SOPs and WPs for Regulatory Affairs Region Europe's * Global responsibilities to ensure compliance with regulatory requirements and guidance documents Requirements: * University degree in medicine, pharmacy, life sciences or chemistry * Minimum of 8 years relevant professionals experience within regulatory affairs and the pharmaceutical industry * Experience with global pharmaceuticals and lifecycle management (clinical development, marketing authorisation application preparation and submission, regulatory support to commercialisation and management of post authorisation issues) * Computer literate with MS Office, eCTD experience and document management systems senior manager, regulatory affairs, global pharmaceutical, lifecycle management, SOPs, Paediatric development, Berkshire