Genpact (NYSE: G) is a global professional services and solutions firm delivering outcomes that shape the future. Our 125,000+ people across 30+ countries are driven by our innate curiosity, entrepreneurial agility, and desire to create lasting value for clients. Powered by our purpose – the relentless pursuit of a world that works better for people – we serve and transform leading enterprises, including the Fortune Global 500, with our deep business and industry knowledge, digital operations services, and expertise in data, technology, and AI.
Inviting applications for the role of Manager- Regulatory Affairs
In this role, you will be expected to work on deadlines, in a fairly high-pressure business
environment while being a good great teammate.
Responsibilities
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Monitor and develop continuous improvement proposals on the processes.
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Maintain a staff of adequately skilled resources to meet deliverables.
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Communicate issues and resolve in an appropriate time frame.
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Ensure adherence to agreed-to work practices.
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Meet established submission timelines and quality standards.
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Participate, as needed, on global teams to complete assignments and tasks within a specific task force/project associated with labeling.
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Ensure collection of metrics required by client.
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Improve speed to client and minimize cost to client
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Identify discrepancies/issues in local implementation of corporate labels and contact the affiliates (if appropriate) for remediation actions
Qualifications we seek in you!
Minimum qualifications
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Demonstrated knowledge and understanding of CCDSs, US and EU labeling, and the
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dynamics of Labeling Team purpose and objectives
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Proven ability to successfully understand regulatory implications of product strategy with regards to the product label, assessment, and practical management of associated impacts
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Ability to work well in cross-functional teams, exhibiting a combination of active listening skills and the confidence to guide decision-making for the document content strategy. Proficient in speaking publicly to senior management when required
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Must be able to construct a Company Response (MAH response) for health authority questions
Masters in Life Sciences
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Understanding of key regulatory and Labeling principles and SOPs
Preferred qualifications
• Should be open to work in any shift as per the business requirement
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 respect and integrity, customer focus, and innovation. Get to know us at www.genpact.com and on X, 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.
