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 : Lead Associate - Regulatory Affairs-LIF008714
Job Description
The Role demands for an experienced Publisher with demonstrated ability to execute responsibility in a highly regulated & process driven environment, the Person will be responsible for all the activities related to
• Publishing and performing technical validation of eCTD submissions for US 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 acknowledgement 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.
• Co-ordinate with client/stakeholders
• Project Management skills
Candidate Profile
• B.Pharm / M.Pharm / Science Graduate
• Experience and have good knowledge of eCTD submissions and Structure & Expertise with Publishing Tools like Liquent Insight Publisher, Lorenz Docubridge, Extedo eCTDManager etc.
• 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
Additional Information
Qualification : B.Pharm / M.Pharm / Science Graduate
Location : Mumbai, Maharashtra
Industry Type : Pharma / Healthcare/ Clinical research
Functional Area : Regulatory Affair
End Date : 10th January, 2023
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