Bayt.com Jobs: Regulatory Officer Job - Pharmaceutical / Medical Company

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Regulatory Officer Job - Pharmaceutical / Medical Company May 20th 2012, 08:03 The Regulatory Officer is responsible to provide input as required at all levels within the Division, the main responsibility is to plan and execute all activities necessary for the registration of new products and line extension indications. The Regulatory Officers ensure the appropriate licensing, marketing and legal compliance of medical products. ESSENTIAL DUTIES: 1 Ensuring that a company's products and all its registration comply with the Ministry regulations. 2 Keeping abreast of international and local legislation, guidelines and customer practices. 3 Collecting and collating a wide range of information, keeping up to date with a company's product range. 4 Developing and writing clear point of view and explanations for new product license and licenses renewals. 5 Preparing submissions of license variations and renewals; setting timelines for license variations and renewal approvals. 6 Understanding and evaluating complex information and planning and developing product trials; interpreting trial data and advising company's on regulatory requirements; 7 Resolving complex issues as arise; preparing and coordinating documentation; 8 Project managing teams of colleagues involved with the development of new products; maintaining quality systems; undertaking and managing regulatory inspections; 9 Reviewing company practices and providing advice on changes to systems; 10 Liaising with, and making presentations to, regulatory authorities; submitting license and clinical trials applications to authorities to strict deadlines; 11 Negotiating with regulatory authorities for marketing authorization. 12 Specifying storage, labeling and packaging requirements, liaising closely with the regulatory authorities on a regular basis. 13 Review of validation, development and stability reports to ensure compliance with licence details and relevant guidelines and directives. Job Details Date Posted: 2012-05-20 Job Location: Al Kuwait, Kuwait Job Role: Engineering Company Industry: Medical/Hospital Joining Date: 2012-05-21 Preferred Candidate Career Level: Mid Career Apply Now - Jobs in Kuwait - Search All Jobs

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