▷ [Immediate Start] Lead Consultant – 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 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