Job Description

With a startup spirit and 90,000+ curious and courageous minds, we have the expertise to go deep with the world&rsquos biggest brands&mdashand we have fun doing it. We dream in digital, dare in reality, and reinvent the ways companies work to make an impact far bigger than just our bottom line. We&rsquore harnessing the power of technology and humanity to create meaningful transformation that moves us forward in our pursuit of a world that works better for people. Now, we&rsquore calling upon the thinkers and doers, those with a natural curiosity and a hunger to keep learning, keep growing. People who thrive on fearlessly experimenting, seizing opportunities, and pushing boundaries to turn our vision into reality. And as you help us create a better world, we will help you build your own intellectual firepower. Welcome to the relentless pursuit of better. Inviting applications for the role of Assistant Manager, Publisher! The Role demands an experienced Publisher with demonstrated ability to execute responsibility in a highly regulated & process-driven environment. Responsibilities . Publishing and performing technical validation (eCTD/CTD/NeeS/Paper) for the Asia Pacific region and 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 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. . Co-ordinate with client/stakeholders . Project Management skills Qualifications we seek in you! Minimum qualifications . 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. Preferred Qualifications . Proven rich experience in Pharmacy Regulatory Affairs Genpact is an Equal Opportunity Employer and considers applicants for all positions without regard to race, color, religion or belief, sex, age, national origin, citizenship status, marital status, military/veteran status, genetic information, sexual orientation, gender identity, physical or mental disability or any other characteristic protected by applicable laws. Genpact is committed to creating a dynamic work environment that values diversity and inclusion, respect and integrity, customer focus, and innovation. For more information, visit www.genpact.com. Follow us on Twitter, Facebook, LinkedIn, and YouTube.

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