IRA, ational Market

Experience: Not Available to Not Available years

Location: Corporate Office|Corp. Office, Ahmedabad, Gujarat, India

Skills: eCTD software, Technical Documents, registration data base, Tender, hospital enlisting, site registration, commercial supply, product launch, artworks

Duties and Responsibilities
Preparation of New registration dossiers as per ACTD, CTD, e-CTD and country specific format. Uploading and Publishing of new registration dossier on eCTD software. Responsible for Life cycle management of drug products in assigned countries. To review of any post approval changes as per current regulatory guidelines. Review of Technical Documents (NPIF, Artwork management, DMF, Product Development Report, BMR, BPR, Specification-STP, Stability Report, CDP Report etc.).



To communicate and follow up with overseas regulatory team or distributors to ensure timely filing and approval of products country wise as per expected approval plan. To Prepare and maintain various registration data base. To provide required documents to marketing to participate in Tender/hospital enlisting. To facilitate site registration activity & approval by different agencies. To provide support/information to various departments for on-going commercial supply as & when requested. To provide inputs for launch recent product & to review various artworks. Compilation and Review of commercial and supporting documents (i.e. Commitments, File Note, SFG-FG Linkage, FSC, LIFs, etc.).

📌 IRA, ational Market (Ahmedabad)
🏢 Zydus Lifesciences
📍 Ahmedabad