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Genpact Limited looking for Regulatory Affairs Lead Associate | M.Pharm, B.Pharm apply

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Genpact Limited looking for Regulatory Affairs Lead Associate

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. Genpacts 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 : Lead Associate - Regulatory Affairs

Job Description
• Publishing and performing technical validation (eCTD/CTD/NeeS/Paper) for the Asia Pacific region and Europe 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.

Candidate Profile
• B. Pham / M.Pharm / Science Graduate  
• In-depth working knowledge of ECTD/CTD/NEES/Paper types of submission, industry-standard publishing systems.
• Effective time management and organizational skills  
• Effectively communication
• Flexibility to adapt to a changing environment
• Have good knowledge of ICH guidelines and CTD Structure & Expertise with Publishing Tools like Liquent, Docubridge, etc.


Additional Information
Qualification : B.Pham / M.Pharm / Science Graduate
Location : Mumbai, Maharashtra
Industry Type : Pharma/ Healthcare/ Clinical research
End Date : 30th October, 2021

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