As a Reg Affairs Officer 1 you will be involved in preparing and reviewing regulatory submissions on behalf of clinical research studies and secures marketing authorizations.You will act as a Regulatory Team Member on small, straightforward regulatory projects and/or get involved in a small single service project, under the guidance of senior staff.You will be responsible for identifying project needs, tracking project timelines, implementing client requests and managing day-to-day workload in collaboration with senior staff, as appropriate.You might be asked to:

• prepare slides and background material for small, straightforward business development meetings under senior guidance and present in client meetings by phone or in person;
• prepare and deliver trainings, as appropriate;
• perform other tasks or assignments, as delegated by Regulatory management;
• making minor changes in systems and processes to solve problems where problems faced are not typically difficult or complex.

Technical Skills/Experience

• degree in life science-related discipline or professional equivalent
• at least 1 years’ experience in regulatory lifecycle maintenance, focusing on marketed products
• preferably has experience of Marketing Authorisation transfer procedures in Europe and/or emerging markets 
• preferably an understanding of pharmacovigilance activities relevant to marketing authorization transfers
• experience of preparation of relevant CTD documents to support submissions (mainly Module 1), in collaboration with technical/CMC/Labelling experts
• able to assist in review and revision of regulatory SOPs / act as reviewer as appropriate.

At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.