Associate Director/Director, Regulatory Affairs – GDP
Shionogi - Florham Park, NJ
Description : The Associate Director/Director, Regulatory Affairs – GDP, provides essential support to the Senior... Director in overseeing regulatory activities related to Quality of Life (QOL) initiatives on a regional and/or global scale...
April 24
Associate Director Regulatory Writing
Novartis - East Hanover, NJ
and safety documentation for submission to regulatory authorities in support of marketing applications. To provide authoritative... of Safety Management Team (SMT). Core member of multiple Clinical Submission Teams (CST). Extended member of Global Clinical...
March 15
Associate Director/Director, Global Epidemiology & Real-World Evidence
Shionogi - Florham Park, NJ
Description : The Associate Director/Director, a member of Shionogi’s Global Epidemiology and Real-World Evidence... (GEE) team, is responsible for strategizing and generating real-world evidence using fit-for-purpose data to support global...
February 1
Senior Director, Regulatory Affairs - GDP
Shionogi - Florham Park, NJ
alignment with company objectives and regional regulatory requirements. Drive the preparation and submission of regulatory... and cross-functional stakeholders. Collaborate with global regulatory counterparts to ensure alignment of regional regulatory...
April 24
Novartis - East Hanover, NJ
global regulatoryenvironment and process (key regulatory bodies, keydocuments, approval processes, safety...: complex Clinical Study Reports (CSR), Development Safety Update Reports (DSUR), Risk Management Plans (RMP), submission...
March 15