Regulatory Affairs Specialist- Pharma Co-Vigilance
Our client is an innovative company leading the way in pharmaceutical manufacturing. Based in the South West, they have in house R&D and product development and are continually looking to provide innovative solutions to support their growth plans, both in the UK and internationally. On their behalf, we now seek to recruit a further member to the Regulatory Affairs department. The company culture is dynamic and fast paced and you should want to join a progressive and growing organisation and be flexible to change with business needs. As the ideal candidate you will have a 'regulatory affairs' background, and a working knowledge or familiarity with NHS systems. You will be analytical and logical in approach, have strong spoken and written communication skills. Good planning and project management skills, IT and mathematical ability are also desired. The role: You will be responsible for the generation and submission of highly complex technical and scientific documentation to Regulatory Agencies (national, European and world-wide), for a successful application to enable the company to gain a Marketing Authorisation and thus sell and market licensed products on a national, European or global stage. You will review licensing projects, and contribute to the product and device licensing planning process. You will be responsible for providing the regulatory affairs team with the necessary product knowledge to enable them to seek Marketing Authorisations for existing unlicensed products or new products to increase the portfolio and exceed commercial plans in line with clinical or business needs. To include; relevant clinical and non-clinical papers, product safety data, products already on the market to be used as reference products and scientific information on the efficacy and stability of the drug product. You will collate Regulatory Agency queries and requests for further information and generating the responses of a product quality and clinical nature. You will maintain the pharmacovigilance system and ensures patient safety by monitoring and evaluating the clinical use of products. You will be responsible for maintenance of technical and scientific data to enable the company to achieve ISO accreditation thus allowing the company to manufacture and sell medical devices across European member states. Please call Gill Price on or email for further details, including a copy of your CV and your salary requirements. The first interviews will be held over skype with Gill Price at the agency.