h3Work Schedule /h3 pStandard Office Hours (40/wk) /p h3Environmental Conditions /h3 pOffice /p h3Job Description /h3 pAs part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer. /p h3Description /h3 pThe Sr Regulatory Affairs Specialist - Regulatory liaison: /p pProvides regulatory advice and carries out projects in the provision of regulatory affairs services: /p ul liActs as liaison with internal stakeholders in the provision of these services. /li liWorks with the Regulatory Affairs Sr Management to perform the day to day operational aspects of the Department such as: assessment of regulatory documents, preparation and assembly of global regulatory submissions, QC review of the final submission package. /li liInterfaces with PPD project teams and Health Authorities regarding regulatory strategy/submission activities. /li liDevelops and maintains a cooperative working relationship with Project Managers and project team members for assigned projects.



/li liAdvises and directs project team as to their responsibilities relative to regulatory strategy/submission activities. /li liActs as a key liaison between Regulatory Affairs Department and project team for assigned projects. /li /ul h3Education and Experience: /h3 ul liBachelor's Degree; degree in Pharmacy or Life Science is an advantage /li liPrevious regulatory experience, or combination of higher education/less experience or substitution of equivalent relevant work experience will be considered /li /ul h3Knowledge, Skills and Abilities: /h3 ul liPrevious Regulatory affairs experience /li liAn appreciation of the requirements, timelines and processes for regulatory applications globally is a valuable asset. /li liPrevious experience with clinical trials application compilation and submissions in EU and other countries is an advantage. /li liExcellent English language communication skills, both verbal and in writing. /li liComputer skills (Microsoft office) and experience in applications used in clinical trials (eTMF, CTMS) would be an advantage /li liGood organizational and planning skills. Ability for multiple project tasking /li liProven ability to work effectively in a team, including in a multinational one /li liProblem solving skills and strong attention to detail /li /ul pThermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status. /p #J-18808-Ljbffr

📌 Sr Reg Affairs Spec - Regulatory Liaison (Italia)
🏢 Thermofisher Scientific
📍 Italia