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.  

We are seeking a support for client in their requested requirement for regulatory submissions that may have impact on registrations of small molecules, biologics and combination products.   

Responsibilities 

Support through a number of regulatory functions specific to post-approval, lifecycle management capacities which includes – 

• Provide scientific inputs and actively involved in RA CMC strategic discussions​ 

• Monitor assumptions, risks and dependencies​ 

Manage and oversee regulatory post approval Chemistry, Manufacturing and Controls (CMC) changes involving deliverables such as:  

• Provide of regulatory evaluation of change control (affected countries, data/documentation requirements per country, change category per country and regulatory procedure per country) and regulatory strategy 

• Provide tracking list and review documentation 

• Dispatch final documentation package to Local Regulatory Affairs (LRA) in affected countries 

• Monitor timely submission and approval in affected countries  

• Manage and coordinate responses to health authority questions  

• Overall planning of all CMC regulatory changes per product together with relevant interfaces  

• Represent G CMC RA in cross-functional teams  

• Experience working for major regulated markets – EU (different types of variations, work sharing/ super grouping), US, Japan, China 

Manage and oversee support for renewals and post approval CMC commitment involving deliverables such as: 

• Provide regulatory requirements and regulatory strategy to relevant interfaces  

• Review documentation  

• Dispatch final documentation package to Regional Regulatory Lead (RRL) for further distribution to LRAs  

• Manage and coordinate responses to health authority questions  

• Overall planning of all renewals per product together with relevant interfaces  

• Represent G CMC RA in cross-functional teams  

CMC management : 

• Authoring of Dossier sections – Module 2 and Module 3 – DS and DP according to the relevant regulatory requirements and GMP rules. 

• Compilation of CMC documents for MAA, renewals, variations, commitments, Response to health authority queries  

• Interaction and cooperation with experts from the relevant departments and CMOs (contract manufacturers and contract laboratories), also in non-European countries, to compile the information and data required for Module 3.2.P. 
  Interaction with competent authorities in the context of ASMF/DMF and CEP activities. 

General tasks: 

• Support and coordination of audit and inspection related activities 

• Maintain up-to-date knowledge of regulatory requirements and guidelines 

• Provide regular progress reports and updates 

• Acting and living in client processes, and systems 

Experience: 

Relevant experience in CMC tasks and related aspects. 

Experience working on biological products required 

Qualifications we seek in you! 

Minimum Qualifications 

Atleast Bachelor's degree required  in for Pharmaceutical: science, engineering, or related field (advanced degree preferred). 

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.