Sr. Consultant - Regulatory Affairs
Ready to turn bold ideas into real-world impact?
At Genpact, we don’t just adapt to change, we lead it. AI and digital innovation are transforming the way businesses work, and we’re at the forefront of it. Genpact’s AI Gigafactory, our industry-first accelerator, exemplifies how we scale advanced technology solutions to help global enterprises work smarter, grow faster, and transform at scale. Whether tackling complex challenges through large-scale models or agentic AI, our breakthrough solutions tackle companies’ most complex challenges.
If you thrive in a fast-moving, innovation-driven environment, love building and deploying cutting-edge AI solutions, and want to push the boundaries of what’s possible, this is your moment.
Genpact (NYSE: G) is an agentic and advanced technology solutions company. We leverage process intelligence and artificial intelligence to deliver measurable outcomes. With a strong partner ecosystem and decades of client trust, we provide innovative solutions that transform how businesses run. Powered by a team with an active learning mindset and client centricity at its core, we deliver lasting value for the world’s leading enterprises.
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Job Description
Inviting applications for the role of lead Consultant Regulatory Affairs Labelling for USA market In this role Candidate should have experience in labelling regulation and requirements for US market including good knowledge of CCDS Non-CCDS and Annual reportable labelling changes. Management process for Product website labeling changes Editorial labeling changes Labeling content development (PM and packaging components) including: CCDS updates and associated label negotiation and HC mandated label updates. Also candidate should have hand on experience of labelling tools. Responsibilities: - Change management process of CCDS Non-CCDS and Annual reportable labelling changes. - Analysis of competitor information (e.g. - labels approval packages) for regulatory policy projects and/or labelling projects - Escalate notify and resolve any issues that may impact final labelling submission. - End to end responsibility of labelling for product registered in US market. - Responsible for maintaining internal tracker for CCDS Non-CCDS and Annual reportable labelling changes and submissions.
Qualifications
Bachelors - Health Administration, Bachelors - Healthcare, Bachelors - Pharmacy, Masters - Public Health, Masters - Regulatory Affairs
Certifications
Certified Compliance Officer (CCO) - VskillsVskills, Regulatory Affairs Certification (RAC) - UdemyUdemy
Required Skills
Change Management, Data Consulting, Data Management, Project Management, Quality Assurance (QA), Regulatory Affair Management, Regulatory Information Management, Strategic Planning
Language
English
Language Proficiency -
Intermediate - B1
Additional Job Location -
Job Type
Regular
Master Skill List -
Regulatory Affairs - Practice
Remote Type -
Hybrid
Work Shift -
Flex Time (India)
Why join Genpact?
- Lead AI-powered transformation – Drive innovation and solve real-world business challenges that matter
- Make an impact – Help global enterprises solve business challenges that matter
- Accelerate your career – Gain hands-on experience, mentorship, and world-class learning opportunities to stay ahead
- 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 140,000+ coders, 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.
