Regulatory Submissions Jobs in Japan

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech we are unique...

As a Regulatory Officer will work closely with our global team of experts to prepare clinical trial dossiers for regulatory and authorities deliver regulatory training to project teams and communicate with stakeholders on regulatory-related matters. Join PSI and help drive innovation and excellence...

Career CategoryRegulatoryJob DescriptionGroup PurposeJapan Regulatory Affairs provides leadership expertise and execution for the regulatory strategy to obtain and maintain clinical trial and marketing licenses for Amgen molecules in Japan in alignment with local business priorities and global regul...

Job Description SummaryProvides regulatory strategy and direction to the business regarding healthcare industry regulatory requirements for product launch premarket submissions/registrations and postmarket compliance working closely with healthcare regulatory bodies globally. Impacts quality of own...

SUMMARY:The Principal Medical Writer (PMW) is the accountable lead for his/her compound(s). The PMW works closely with Medical Directors Biostatisticians Regulatory Liaisons and others to develop high-quality clinical documents and is responsible for helping to drive document strategy development an...

Job Summary:To provide specialist regulatory knowledge and support for chemicals to ensure the regulatory compliance of these materials for both internal and external customers. Learning the requirement of and supporting the CSCL regulatory business.This role contributes to departmental revenue targ...

Job Description SummaryWe are seeking a highly motivated Regulatory Affairs Manager to lead regulatory strategies and ensure compliance for pharmaceutical and medical device products. This role plays a critical part in supporting product launches regulatory submissions and post-market activities whi...

Job Overview:Line manage PSS staff including performance reviews human resource issues and assist Senior PSS Management in assigning resources to projects.Manage the overall PSS operations associated with products including the entire adverse events process; which may include safety data collected f...

Work Flexibility: Hybrid or OnsiteKey Areas of Responsibility:Assesses regulatory intelligence to assist in the development of local regional and global regulatory strategies Participates in advocacy activities of a technical and/or tactical natureEvaluates the regulatory environment and contribute...

Career CategoryRegulatoryJob DescriptionGroup PurposeJapan Regulatory Affairs provides leadership expertise and execution for the regulatory strategy to obtain and maintain clinical trial and marketing licenses for Amgen molecules in Japan in alignment with local business priorities and global regul...