Job Description

Ready to shape the future of work?
At Genpact, we don't just adapt to change--we drive it. AI and digital innovation are redefining industries, and we're leading the charge. Genpact's AI Gigafactory, our industry-first accelerator, is an example of how we're scaling advanced technology solutions to help global enterprises work smarter, grow faster, and transform at scale. From large-scale models to agentic AI, our breakthrough solutions tackle companies' most complex challenges.
If you thrive in a fast-moving, tech-driven environment, love solving real-world problems, and want to be part of a team that's shaping the future, this is your moment.
Genpact (NYSE: G) is an advanced technology services and solutions company that delivers lasting value for leading enterprises globally. Through our deep business knowledge, operational excellence, and cutting-edge solutions - we help companies across industries get ahead and stay ahead. Powered by curiosity, courage, and innovation, our teams implement data, technology, and AI to create tomorrow, today. Get to know us at genpact.com and on LinkedIn, X, YouTube, and Facebook.
Inviting applications for the role of Lead Consultant- Regulatory Affairs - Labelling!
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

• Monitor and develop continuous improvement proposals on the processes.
• Maintain a staff of adequately skilled resources to meet deliverables.
• Communicate issues and resolve in an appropriate time frame.
• Ensure adherence to agreed-to work practices.
• Meet established submission timelines and quality standards.
• Participate, as needed, on global teams to complete assignments and tasks within a specific task force/project associated with labeling
• Ensure collection of metrics required by Sanofi.
• Improve speed to Sanofi and minimize cost to Sanofi
• 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

• Demonstrated knowledge and understanding of CCDSs, US and EU labeling, and the dynamics of Labeling Team purpose and objectives
• Proven ability to successfully understand regulatory implications of product strategy with regards to the product label, assessment, and practical management of associated impacts
• 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
• Must be able to construct a Company Response (MAH response) for health authority questions

Masters in Life Sciences

• Understanding of key regulatory and Labeling principles and SOPs

Preferred Qualifications/ Skills

• Should be open to work in any shift as per the business requirement

Why join Genpact?

• Be a transformation leader - Work at the cutting edge of AI, automation, and digital innovation
• Make an impact - Drive change for global enterprises and solve business challenges that matter
• Accelerate your career - Get hands-on experience, mentorship, and continuous learning opportunities
• Work with the best - Join 140,000+ bold thinkers and problem-solvers who push boundaries every day
• Thrive in a values-driven culture - Our courage, curiosity, and incisiveness - built on a foundation of integrity and inclusion - allow your ideas to fuel progress

Come join the tech shapers and growth makers at Genpact and take your career in the only direction that matters: Up.
Let's build tomorrow together.
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.
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.

Skills Required