Senior Manager Regulatory Affairs

Recruiter
Regulatory Professionals
Location
United Kingdom
Posted
27 Sep 2017
Closes
03 Nov 2017
Sector
Healthcare
Contract Type
Permanent
Hours
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