End to end exposure w.r.t. review/reg.strategy right from development through optimisation, tech transfer, EB Batches, filing of ANDA/NDA of sterile Injectable not limited to conventional SI, preferably inclusive of complex SI (i.e. Peptides, PFS, Bags, Long Acting Injectables, and Liposome Injectables etc).
Added advantage to the candidates who have prior handsome exposure to Drug Device combination products/Human Factor studies etc.
Review independently each technical documents of SI in compliance to respective US FDA regulatory/ICH/Compendia GP etc requirements.
Participation in Cross Functional Team Internal/External and contributing towards the progress of the projects accomplishment.
Should have proactive planning and organisation skill in preparing/drafting the requisite correspondence(s) (i.e. CC, Meeting requests etc ) to US FDA in time so as to avoid any delay on the assigned projectss progress.
Should have handsome experience in eCTD w.r.t. compilation of new ANDA/NDA and the respective Life cycle management (LCM) submissions.
Employement Category:
Employement Type: Full time Industry: Pharma / Biotech Role Category: Corporate Legal Department Functional Area: Not Applicable Role/Responsibilies: Senior Associate / Assistant