Ph3Overview /h3 pJob Title: SENIOR REGULATORY AFFAIRS SPECIALIST /p pDepartment: Clinical /p pPhilogen S.p.A., a biotech company listed on the Milan Stock Exchange and a leader in the development of innovative anti-tumor therapies, is looking for a highly motivated and qualified Senior Regulatory Affairs Specialist who will report to the Regulatory Affairs Manager and will provide support in formulating and implementing regulatory strategies for the development of Company Products in close collaboration with other functions in the Clinical Department. /p pbIn particular, the selected candidate will carry out the following tasks: /b /p h3Responsibilities /h3 ul liLead and manage activities concerned with the submission and approval of products and product transfers to government regulatory agencies including US and EU regulatory bodies: /li liDevelop content, timelines and contingencies for submissions in collaboration with internal and external contributors /li liEnsure that submissions are of high quality, meet all regulatory requirements and comply with corporate goals and directives /li liReviewing draft registration files and submitting new and amended registration dossiers to obtain and maintain registration /li liGathering, evaluating, and organizing information necessary for regulatory agencies and other third parties; /li liCoordinate and participate in the preparation of different types of regulatory submissions (e.g. dossier, variations, scientific advice submissions, INDs) to competent authorities worldwide for approved and developmental products /li liProvide regulatory feedback to project teams and senior management /li liParticipate in contacting competent authorities for respective projects/products and interact with internal departments /li liPerforming the registration, update and posting of results of Philogen studies in mandatory clinical trials and publication databases; /li liManagement of procedures related to Marketing Authorisation Applications for EMA and FDA; /li liManaging the update of the Trial Master File and archiving of the documentation regarding the Competent Authorities and Ethics Committees of all Philogen studies in collaboration with the CTA; /li liPrepare and revise controlled documents including clinical Forms, Templates and Standard Operating Procedure (SOPs) referred to the Regulatory Affairs; /li liTraining clinical staff in regulatory policies or procedures; /li liKeeping up-to-date with changes in regulatory legislation and guidelines and evaluating applicable laws and regulations to determine impact on department activities; /li liPreferably experience of but definitely an awareness of the key electronic submission tools /li /ul h3Qualifications /h3 ul liUniversity degree in science (preferred) /li liAt least 5 years’ experience in regulatory affairs /li liExperience in Regulatory Life Cycle Management and eCTD is an advantage, although not required /li liA thorough understanding of ICH GCP and regulatory requirements worldwide (particularly FDA and EMA) /li liExcellent written and oral communication skills. /li liAn excellent level of English, both written and spoken. /li /ul h3We offer /h3 pA contract and salary proportional to the experience of the successful candidate /p h3Job location /h3 pWe invite interested candidates to submit their applications expressly authorizing the processing of personal data in accordance with Legislative Decree 196/2003. Our recruitment adheres to the provisions of Legislative Decree 198/2006, and we welcome applications from candidates of any gender orientation or expression, sexual orientation, age, ethnicity, or religious belief. /p /p #J-18808-Ljbffr