Genpact Limited, a global leader in business process and technology management services, leverages the power of smarter processes, smarter analytics and smarter technology to help its clients drive intelligence across the enterprise. Genpact’s Smart Enterprise Processes (SEP) framework, its unique science of process combined with deep domain expertise in multiple industry verticals, leads to superior business outcomes.
Post : Technical Associate – Reg. Affairs-LIF006489
• Publishing and performing technical validation (eCTD/CTD/NeeS/Paper) for the LATAM and Canadian Submissions. • Performing final technical quality review. • Dispatching submission to the relevant authority ((eCTD/CTD/NeeS/Paper) or affiliate so that affiliate can dispatch to authority; • Performing post-submission processing activities such as receiving acknowledgment from authority of submission receipt; capturing and the electronic receipt and metadata in RIM; communicating submission receipt to key stakeholders; • Capturing submissions-related correspondence from health authorities, such as uploading documentation, commitments, and metadata.
• B.Pham/M.Pharm/Science Graduate • In depth working knowledge of ECTD types of submission, industry standard publishing systems. • Effective time management and organizational skills • Effectively communication • Flexibility to adapt to a changing environment • Good knowledge of ICH guidelines and CTD Structure & Expertise with Publishing Tools like Liquent, Docubridge, etc. • Experience in Pharmacy Regulatory Affairs
Qualification : B.Pham/M.Pharm/Science Graduate Location : Mumbai, Maharashtra Industry Type : Pharma / Healthcare/ Clinical research Functional Area : Regulatory Affair