This role will be responsible for managing the regulatory activities for US NDAs and Labeling. This role needs a seasoned professional who is aware of the regulatory activities for NDAs, can work in R & D CFT and who has the management capability of leading a group of FTEs.
This role is responsible for delivering filing and approval target for NDAs for US, EU and other advanced markets.
This position holder is required to work closly with R & D and other cross functional team leads in the organisation including BD, SGO, MSTG, Procurement and quality to ensure successful lifecycle management.
Providing regulatory strategy to R & D for NDA products being developed for US and other advanced markets like EU & Canada
Ensure Timely filings of pIND, scientific meeting request, IND,Pre NDA, NDA.
Ensure adequate and timely response to deficiencies securing timely approval as per agency timelines
Manage the regulatory team responsible for US and Canada
Ensure lifecycle management through timly submission of annual reports, supplements etc to ensure product continuity
Collaborate with HoD in meeting department goals.
Experience should not less than 18 yrs and have good understanding of Generic pharmaceutical Industry
Hands of expertise of preparation & review of dossiers, response to quires, communication with agencies.
Spectrum Talent Management is a forerunner in designing Human Resources solutions specific... to the local needs of our respected clients. Providing services to clients globally our unique implementation methodology has been developed for speedy ramp-up to cater to the ever urgent needs of the industry as well as ensuring that we apply systems, measures and best practice processes in order to meet the demanding SLAs set by our clients. Read full description