Mt -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._
- Responsibilities_
- 1. Change control assessment and prepare regulatory strategy documents for the change variations._
- 2. Strategize and provide CMC support for innovation projects/site transfer/due diligence assessment._
- 3. Strategy preparation for the EU variation submissions - Work sharing, Super grouping, Annual reports._
- 4. Coordinate and support dossier preparation, review in line with regulatory requirements to finalize the submission._
- 5. Assessment of Deficiency letters from HA and coordinate with stake holders for HAQ responses for timely submission._
- 6. Act as the primary point of contact between global Regulatory CMC and local affiliates for submission package preparation and delivery._
- 7. Translate global CMC strategies into actionable regional plans, ensuring alignment with country-specific requirements._
- 8. Plan the due dates and coordinate the on-time delivery of the document, to meet regulatory submission timelines._
- 9. Creation & maintenance of Veeva activities such as ROs, Submissions, Registrations etc in Veeva Vault before/after Submission/ Approval._
- 10. Active Participation in the project meetings and provide inputs as necessary._
- 11. Maintaining the related trackers and update the information accordingly._
- Qualifications we seek in you_
- Minimum Qualifications_
- _Pharmaceutics, Chemistry background is preferred._
- _Experience required in CMC Regulatory handling for EU/US regions._
- _Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support._
- _Strong practical experience with global HA requirements, beyond EU/US._
- _Proven ability to understand and communicate regulatory strategy to drug development, registration, and post-market support teams._
- _Able to deal with issues of critical importance with mínimal oversight. Exercises good judgment in elevating and communicating actual or potential issues to line management._
- o Understands who is responsible for different decisions and escalates as necessary._
- o Applies directions taken by the company._
- _Demonstrates emerging leadership, problem-solving ability, flexibility and values teamwork._
- o Intentionally promotes an inclusive culture._
- o Applies given prioritization framework with limited support._
- _Excellent written and oral communication skills required._
- _Excellent skills in leadership, collaboration, negotiation, problem solving, and fostering interpersonal connections through teamwork._
- Preferred Qualifications/ Skills_
- 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._

**_
Job_**_Lead Associate_

**_ Primary Location_**_India-Hyderabad_

**_ Schedule_**_Full-time_

**_ Education Level_**_Bachelor's / Graduation / Equivalent_

**_ Job Posting_**_Sep 15, 2025, 1:13:01 AM_

**_ Unposting Date_**_Ongoing_
- Master Skills List_Operations_
- Job Category_Full Time_