Job Description :
Director of Regulatory Affairs Labeling
Basking Ridge, NJ
Length: 12 + Months
Interview: Phone, In Person or Skype
Job Description:
Duties:
This position serves as the Regulatory Affairs labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product labeling in collaboration with Global Regulatory Leads (GRLs
This position may serve as an ad hoc member of Global Project Team (GPT) to address labeling issues for late stage projects.
This position manages multiple assigned projects of increased complexity including post marketing projects and those involving 3rd party development.
This position partners with GRLs and Clinical Safety Pharma covigilance (CSPV) leads in the maintenance of Company Core Data Sheets (CCDS) for assigned products.
This position drives/leads the maintenance of global labeling and associated documents (including cartons and external packaging in the US) for assigned Daiichi Sankyo products.
This position ensures that draft labeling complies with all applicable regulations and guidelines and with Company Core Data Sheets and manages deviations.
This position interacts across the RA function globally and interacts across functional as well as regional areas.
This position often works with ambiguity and complex problems, focusing on strategic and operational decisions.
Skills:
10 years pharmaceutical industry experience required with 5+ years of direct regulatory affairs experience, including US labeling experience
Experience with ex-US labeling a plus (outside the US)
Thanks and Regards,
Shivangi Singh | Team Lead | KPG99, INC
Certified Minority Business Enterprise (MBE)
Direct| |