Regulatory Associate_ Japanese speaker (fixed term contract)

Join us on our exciting journey!We are recruiting people to join our Regulatory Affairs Team on a temporary contract.Proactive monitoring and surveillance on changes in the global regulatory landscape covering the drug development lifecycle starting from preclinical through commercialization as well as the medical devices from concept stage to market. This position will provide broad support on clinical, pharmacovigilance and manufacturing quality activities and requests.RESPONSIBILITIES• Monitor and analyse the changes and evolution of the local regulatory environment, including guidance and regulations from regulatory authorities, trade organizations, working groups, and relevant industry thought leaders for both drug and medical devices.• Assess regulatory intelligence information for relevance and impact to industry’s internal processes, drug development projects and/or regulatory strategies to create and enrich the IQVIA proprietary documents.• Monitoring agency and professional websites, local specialized press, conferences and selecting documents to be integrated in line with the IQVIA scope, editorial and intelligence management processes.• Synthesize information from regulatory documentation as well as interaction with local country experts as needed.• Share/Input data into systems or tools to enable effective knowledge management of country level operational intelligence data.REQUIRED KNOWLEDGE, SKILLS AND ABILITIESESSENTIAL• Proficient in proof reading and editing in English language• Proficient in Japanese• Capability to work remotely with peers in an international environment• Ability to research, analyse and extrapolate critical information.• Effective communicator - - both written and oral.• Highly organized and able to work independently to meet deliverable on time and on target.• Attentive to details and focused on quality output l - in a multi-discipline team environment.• Proficient in the navigation of intelligence database(s).DESIRABLE• Experience in the biotech/pharmaceutical industry .• Experience with understanding and interpreting regulatory guidelines and documents .• Strong understanding of the commercial aspects of the healthcare market.

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