Senior Manager - Regulatory Affairs

Ready to shape the future of work?

At Genpact, we dont just adapt to changewe drive it. AI and digital innovation are redefining industries, and were leading the charge. Genpacts AI Gigafactory, our industry-first accelerator, is an example of how were 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 thats shaping the future, this is your moment.

Genpact (NYSE: G) is anadvanced technology services and solutions company that deliverslastingvalue for leading enterprisesglobally.Through ourdeep 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 teamsimplementdata, technology, and AItocreate tomorrow, today.Get to know us atgenpact.comand onLinkedIn,X,YouTube, andFacebook.

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

Lets 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.