Lead Associate – Regulatory Affairs Jobs | Explore Genpact Careers
Explore exciting Regulatory Affairs Jobs with Genpact Careers and take your career to the next level. The Lead Associate – Reg Affairs role offers a dynamic work environment powered by AI, digital innovation, and global impact. If you’re a pharmacy professional looking for growth in regulatory operations, this opportunity at Genpact Careers is your gateway to shaping the future of healthcare and pharma compliance.
Job Details:
- Job Title : Lead Associate – Reg Affairs (LIF022517)
- Location: India-Mumbai
About The Company:
Genpact (NYSE: G) is a global technology services and solutions leader delivering innovative digital and AI-powered solutions. Explore Regulatory Affairs Jobs at Genpact Careers and contribute to operational excellence across industries. Through curiosity, innovation, and expertise, Genpact transforms data and technology into actionable outcomes.
Key Responsibilities At Regulatory Affairs Jobs:
- The Role demands for a publisher with demonstrated ability to execute responsibility in a highly regulated & process driven environment, the Person will be responsible for all the activities related to.
- Publishing and performing technical validation of eCTD for US submissions.
- Performing final technical quality review.
- Dispatching submission to the relevant authority (eCTD/CTD/NeeS/Paper) or affiliate so that affiliate can dispatch to authority.
- Performing post-submission processing activities such as receiving acknowledgement from authority of submission receipt; capturing and the electronic receipt and metadata in RIM; communicating submission receipt to key stakeholders.
- Capturing submissions-related correspondence from health authorities, such as uploading documentation, commitments and metadata.
Qualifications Required For Regulatory Affairs Jobs:
- Bachelor’s degree, preferably in Pharmacy, Medicine, Chemistry, or related Life science discipline required with relevant experience in the pharmaceutical industry.
- Mandatory Knowledge of ICH and FDA guideline for US market.
- Working knowledge of eCTD/ CTD/NEES types of submission, industry standard publishing systems.
- Should be advance level in English language.
- In depth working knowledge of eCTD/CTD/NEES/Paper types of submission, industry standard publishing systems.
- Effective time management and organizational skills.
- Effective communication.
- Flexibility to adapt to a changing environment.
- Experience and have good knowledge of ICH guidelines and CTD Structure & Expertise with Publishing Tools like Liquent, DocuBridge, etc.
Why Join This Company?
- 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.
