Regulatory Affairs Specialist (maternity leave) At AstraZeneca we believe in the potential of our people and you'll develop beyond what you thought possible. We make the most of your skills and passion by actively supporting you to see what you can achieve no matter where you start with us.As Regulatory Affairs Specialist (maternity leave) in Italy, you will play a pivotal role in channelling our scientific capabilities to make a positive impact on changing patients' lives.Our scientific research is absolutely forefront in Oncology, Respiratory, CardioRenal Metabolic diseases and one of the most promising in the whole industry. You will be among inspiring industry leaders who will keep you engaged and empower you to be the best. We seek out opportunities to do dynamic and significant work which means we won't just follow the same course of action time and again if we can see potential in a different way of building life changing medicines.As Regulatory Affairs Specialist you will collaborate to achieve and maintain regulatory authorisations for the new and existing products pertinent to AstraZeneca Therapeutic Areas of focus, in compliance with local legislation and MC Code/SOPs, as well as guarantee the maintenance and compliance to GRP and local SOPs.If you're inspired by the possibilities of science to make a difference and ready to discover what you can do – join us.MAIN DUTIES AND RESPONSIBILITIESThe role broadly includes the following key components:Supporting all activities related to the registration and maintenance of products in compliance with all local and global codes, standards and proceduresAssisting with regulatory file compilation and submissions, regulatory approval and maintenance procedures including maintenance of regulatory databasesFollowing up the variations approval process implementing the regulatory activities established by the law and by AstraZenecaMaintaining regulatory/technical archive of product and tracking of submission/achievements being able to satisfy the requirements of any audit or inspectionReviewing of promotional materials, from a regulatory point of view, in order to guarantee the compliance with local legislation and MC Code/SOPsManage all activities and Account relationship according with Company Values, Code of Conduct, Guidelines/Internal procedures and Italian legislationESSENTIAL REQUIREMENTSScientific DegreePreferable 1 or 2 years of professional experience in Regulatory Affairs field within a pharmaceutical company or health care authorityGood knowledge of National and EU pharmaceutical legislationKnowledge of the local and HQ SOP and CodesKnowledge of informatics system and programsExcellent communication and teamwork skillsPrecision and accuracyFlexibilityFluent in Italian and English DESIDERABLE REQUIREMENTS Futher qualification/Master in Regulatory field Next Steps – Apply today!To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Line Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.Date Posted15-kwi-2024Closing Date29-kwi-2024
