PAREXEL values passion, global perspective and expertise and we are in the process of recruiting full time, permanent Regulatory Affairs Consultant (CMC focused) to join our PAREXEL Consulting team in Bucharest. PAREXEL Consulting offers services which create and maximize product value for clients throughout the product lifecycle, leveraging our unique fusion of scientific, regulatory, and business expertise. We are the pre-eminent regulatory and GxP (Good Clinical, Laboratory, or Manufacturing Practice) compliance consulting practice in the world.
Main responsiblities include:
• Variation/Lifecycle Maintenance compilation/submission’s coordination for EU/RoW regions: e.g. Simple (Type I), complex variations (Type II) to EU markets in the CP and NP procedures, Renewals etc. • Change Control assessment experience or transferrable skills (application of relevant regulatory guidance to proposed change) • Participating in discussion on regulatory strategies with a wide stakeholder network (QA, Brand Leads etc.) with support of an SME. • Strict adherence to timelines (both internal and HA deadlines).
• Good understanding of performing the above regulatory tasks on a global level. • Several years of Variation/ Lifecycle Maintenance experience. • Relevant CMC Regulatory expertise. • Good project Management skills. • Proactive approach and excellent communication skills. • Fluent English and Romanian.