Job Description

With a startup spirit and 115,000+ curious and courageous minds, we have the expertise to go deep with the world\xe2\x80\x99s biggest brands\xe2\x80\x94and we have fun doing it. We dream in digital, dare, and reinvent the ways companies work to make an impact far bigger than just our bottom line. We are 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 are 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 Manager, Regulatory Information Management
As an expert in regulatory information management, you will have the opportunity to be a part of a passionate group and help our esteemed clients achieve data drive transformation
Responsibilities:
Main Responsibilities include:

• Provide subject matter expertise on ISO Standards, EU Implementation Guide and SPOR implementation
• Support end to end data preparation & readiness: data assessment, data remediation, data transformation, data enrichment and data completeness
• With good understanding of regulatory information management & associated business processes, provides expertise in managing data & processes in a global RIMS platform
• Contribute to implementation of Regulatory Information Management system / platform and associated data processes & data operations
• Communicates & collaborates effectively with different groups both on the business & IT side, including senior stakeholders \xe2\x80\x93 ability to articulate complex scenarios succinctly and targeted to the group
• Ensure customer success throughout the engagement

Qualifications we seek in you:
Minimum Qualifications

• Relevant experience in the field of Regulatory Information Management within the Pharmaceutical Industry
• Expertise and working knowledge with ISO Standards, EU Implementation Guide, SPOR implementation, xEVMPD
• Experience with data assessment, data enrichment, data transformation and data readiness
• Experience supporting implementation & maintenance of data standards \xe2\x80\x93 naming convention, reference data standards, master data standards
• Reasonable understanding of functional processes \xe2\x80\x93 Registration Management, Submission Planning & Management, Content Management
• Reasonable understanding of Regulatory business processes \xe2\x80\x93 Marketing Authorization Applications, License Renewals, Variations, Labeling Submissions
• Experience with implementation of Regulatory Information Management systems
• Effective communication, presentation and interpersonal skills, ability to collaborate and engage effectively with the entire eco system (customer, vendor, Genpact)
• Good understanding & experience with Veeva RIMS, data model and processes
• Experience with multiple RIMS platforms is an advantage
• Ability to lead a team of direct or matrixed colleagues to deliver on business commitments and project timelines
• Expert on life sciences compliance and computer systems validation requirements

Required Education

• Bachelor\'s degree required in science, engineering, or related field (advanced degree preferred)

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.
Furthermore, please do note that Genpact does not charge fees to process job applications and applicants are not required to pay to participate in our hiring process in any other way. Examples of such scams include purchasing a \'starter kit,\' paying to apply, or purchasing equipment or training.

Genpact