Regulatory Affairs Senior CMC Officer

<p>DEMO SA, one of the world's largest pharmaceutical manufacturers in injectable facilities, is currently looking for a talented Regulatory Affairs CMC Officer to join our team in Athens (Kryoneri). This position reports directly to the Regulatory Affairs CMC Manager.</p><p></p><p><strong>Main duties and responsibilities:</strong></p> <ul> <li>Understanding of Regulatory strategy and documentation requirements</li> <li>Act as responsible Regulatory Team member for assigned regulatory projects</li> <li>Liaise with various departments to collect all necessary information and documentation, in accordance with defined guidelines for Pharmaceutical Dossier submission and product registration</li> <li>Support internal activities of Regulatory department in order to ensure regulatory compliance of registered products</li> <li>Liaise with external Regulatory authorities as required</li> <li>Preparation of submissions including CMC variation filling</li> </ul><p><strong>Requirements</strong></p><ul> <li>BSc Degree in Chemistry, Biology or relevant field.</li> <li>4-6 years of experience in Regulatory Affairs / CMC within a Pharmaceutical organization</li> <li>Knowledge of CMC and global regulatory guidelines</li> <li>Fluency in English and good use of MS Office skills</li> <li>Strong organization skills, multi-tasking and able to meet deadlines</li> <li>Effective communication and relationship management</li> <li>Ability to work under pressure, resilience</li> </ul><p><strong>Benefits</strong></p><p>The Company offers competitive remuneration, continuous learning and development opportunities, and a friendly and challenging working environment.</p>