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.
This program is intended to support client in their requested requirement for regulatory submissions that may have impact on registrations of small molecules, biologics and combination products.

Responsibilities
.Maintain global regulatory oversight of assigned established products
.Representation of Global Regulatory Affairs (GRA) in product-specific cross functional teams
.Establish global regulatory strategies that ensure keeping the assigned established products on the market globally
.Experience in directly detailing with EMA (communication, negotiation), meetings for Centrally approved products (CAP)
.Well versed with EU guidelines and procedures for CAP, MRP / DCP, super grouping work sharing
.Provision of regulatory guidance and operational excellence for worldwide regulatory maintenance activities for assigned medicinal products, including but not limited to , Line Extensions, Renewals, Variations (Type 1A, Type 1B, Type 11) , Periodic Safety Reports (e.g. PSUR), Risk Management Plans, Direct Healthcare Professional Communication, HA Requests, HA Interactions (e.g. Scientific Advice), Referrals, Production Transfers, Marketing Authorization Transfers or Withdrawals, Marketing Authorization Applications in the context of late geographical expansion, Post-marketing Clinical Trial Activities, etc.
.Provision of global strategic regulatory guidance and input to key regulatory documents (e.g., CTD Modules 2, 4, 5 and selected Module 1 parts) according to international regulatory standards as well as Client processes.
.Maintain up-to-date knowledge and oversight of global regulatory requirements, guidelines, evolving regulatory trends and developments as well as monitoring of relevant product-specific competitor information
.Management of lifecycle submissions (Variations, PSURs/PBRERs according to the products)
.Prepare content plan and Finalise cover letter
.Collection of document requirements according to the request and timelines
.Dispatch package to Local country representatives or HA and archival of package in archival system
.Request of registration samples
.Coordination and preparation of supportive documents (general statements, CPPs etc.) including legalisation of documents
.Support and coordination of audit and inspection related activities
.Acting and living in client processes, and systems
Experience:
Relevant experience in life cycle management of products.
Qualifications we seek in you!
Minimum Qualifications
Atleast Bachelor%27s degree required in for Pharmaceutical: science, engineering, or related field (advanced degree preferred).
Language: English
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 %27starter kit,%27 paying to apply, or purchasing equipment or training.