Lead Consultant – Regulatory Affairs

Hyderabad - India

Monthly Salary: Not Disclosed

Posted on: 16 hours ago

Vacancies: 1 Vacancy

Job Summary

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 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 and on LinkedIn X YouTube and Facebook.
Inviting applications for the role of Lead Consultant- Regulatory Affairs - Labelling!
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 labelling
Ensure collection of metrics required by the client
Improve speed to the client and minimize cost to the client
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 labelling and the dynamics of Labelling 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
Understanding of key regulatory and Labelling principles and SOPs

Preferred Qualifications/ Skills
Masters in Life Sciences
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 140000 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.

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