Manager Regulatory - Affairs

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 Manager Regulatory Affairs-Labeling Strategist
Responsible for the review, development, and maintenance of pharmaceutical product labeling to ensure compliance with global regulatory requirements, internal standards, and market needs. This includes managing updates to labeling content, coordinating cross-functional input, and supporting product launches and lifecycle changes.
Responsibilities
Key Responsibilities:
.Label Content Management:
oReview and update product labels, cartons, and inserts in accordance with FDA, EMA, CDSCO, and other global regulatory requirements.
oEnsure labeling reflects accurate product information including indications, contraindications, dosage, warnings, and usage instructions.
.Regulatory Compliance:
oMonitor changes in labeling regulations and assess impact on existing products.
oConduct gap assessments and develop remediation plans to maintain compliance.
.Cross-Functional Collaboration:
oWork with Regulatory Affairs, Quality, Marketing, Legal, and Manufacturing teams to gather input and finalize labeling content.
oLead or support labeling-related projects such as new product launches, market expansions, or regulatory updates.
.Documentation and Systems:
oMaintain labeling records in electronic document management systems (e.g., Veeva Vault, SmartSolve).
oInitiate and manage Change Control documentation for labeling updates.
.Quality and Process Improvement:
oSupport audits and inspections by providing labeling documentation and ensuring traceability.
oContribute to the development and revision of SOPs related to labeling processes.
Qualifications we seek in you!
.Bachelor's degree in Pharmacy, Life Sciences, or related field.
.Experience in pharmaceutical labeling or regulatory affairs.
.Strong understanding of global labeling regulations (FDA, EU MDR, CDSCO).
.Proficiency in Microsoft Office and labeling software (e.g., Adobe InDesign, BarTender).
.Excellent attention to detail, communication, and project management skills.
Minimum Qualifications
Preferred Qualifications/ Skills
.Experience with global labeling strategy and CCDS (Company Core Data Sheet) development.
.Familiarity with UDI (Unique Device Identification) and GS1 standards.
.Technical writing and proofreading skills.
.Ability to work independently and manage multiple projects under tight deadlines.
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 %27starter kit,%27 paying to apply, or purchasing equipment or training.