Regulatory Officer (m/f)

We are seeking for our office based in Zagreb 1 (one) candidate for the position of Regulatory Officer. Responsibilities Regulatory Officer is a member of the Regulatory and Safety Department that is primarily responsible to ensure successful compilation, submission, and maintenance of submissions/notifications to ethics committees and regulatory authorities in the frame of clinical studies, including safety reporting from clinical trials, in accordance with the applicable laws and regulations, as well as applicable Standard Operating Procedures (SOPs) and current Good Clinical Practice (GCP). Regulatory Officer is responsible for set up and maintenance of a detailed overview of ethics and/or regulatory submission activities, including supplementary submission/notification status tracking of the approved studies in line with applicable regulations and ordinances. Regulatory Officer is also responsible for review, preparation and negotiations of clinical trial agreements with health care institutions.

Education - University degree, preferably in Pharmacy or medical and life sciences. Experience and knowledge - Relevant experience is not required, but experience in clinical research within CRO and/or Biopharmaceutical environment is an advantage - Knowledge of ICH GCP Guidelines as well as Ethics, Regulatory and Safety reporting requirements and relevant legislation both in the EU and non-EU countries is preferred - Strong interest in clinical research - Fluent in local language and in English, both, written and verbal - Computer proficiency is mandatory Skills and personality - Ability to read, analyze, and interpret common scientific and technical journals - Excellent verbal and written communication skills - Affinity to work effectively and efficiently in a matrix environment - Very good interpersonal skills, attention to details and reasoning ability If you are interested in joining Optimapharm team, please send your CV in Croatian and in English till 14 December 2016 the latest. Please note that only shortlisted candidates that meet the requirements will be contacted for further selection process.