Pharmacy Job at Genpact | Apply Now for the Lead Associate Role
Genpact is inviting applications for the role of Lead Associate – Regulatory Affairs Operations Global based in Mumbai, India. This Pharmacy Job is ideal for experienced professionals with a Bachelor’s degree in Pharmacy, Medicine, or Life Sciences and a deep understanding of ICH and FDA guidelines. The Lead Associate will manage the end-to-end eCTD publishing process for US submissions, including technical validation, quality reviews, and dispatching to relevant health authorities. Candidates must have expertise with industry-standard publishing tools such as Liquent and DocuBridge to thrive in this highly regulated environment.
- Job Title: Lead Associate
- Location: India-Mumbai
About The Company
Genpact is a global advanced technology services and solutions company that creates lasting value for leading enterprises worldwide. With a workforce of over 140,000 bold thinkers, Genpact drives digital transformation through its industry-first AI Gigafactory, scaling advanced solutions like agentic AI to help businesses grow faster and work smarter. The organization is built on a foundation of integrity, inclusion, and innovation, empowering teams to solve the world’s most complex challenges.
Responsibilities of the Pharmacy Job
- The Role demands 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 the affiliate can dispatch to the authority.
- Performing post-submission processing activities such as receiving acknowledgement from the authority of submission receipt; capturing and the electronic receipt and metadata in RIM, and communicating submission receipt to key stakeholders.
- Capturing submissions-related correspondence from health authorities, such as uploading documentation, commitments, and metadata.
Education and Experience
- Bachelor’s degree, preferably in Pharmacy, required with relevant experience in the pharmaceutical industry is required for the Genpact Job.
- Mandatory Knowledge of ICH and FDA guidelines for the US market.
- Working knowledge of eCTD/ CTD/NEES types of submission, industry standard publishing systems.
- Should be advanced level in the 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.
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.
