Regulatory Affairs Associate Job at Genpact | Life Sciences Candidates, Apply Now
Ready to shape the future of work in a tech-driven environment? Genpact is inviting applications for a Lead Associate – Regulatory Affairs Operations Global. This critical regulatory affairs associate role directly contributes to the company’s revenue growth by leading operational teams in the regulatory space. If you have mandatory knowledge of ICH/FDA guidelines and thrive in a highly regulated environment, join the Genpact career track and leverage your expertise to accelerate regulatory success for global enterprises in this vital life sciences job.
- Designation: Lead Associate – Regulatory Affairs Operations Global
- Location: Mumbai
About The Company
Genpact (NYSE: G) is an advanced technology services and solutions company that delivers lasting value for leading enterprises globally. The company drives change using its AI Gigafactory and digital innovation, helping global enterprises tra
nsform at scale. Powered by curiosity, courage, and innovation, Genpact’s teams implement data, technology, and AI to create tomorrow, today. When you join Genpact, you join 140,000+ bold thinkers committed to accelerating your Genpact career and fueling progress globally.Key Responsibilities
This leadership role contributes directly to revenue growth by heading operational teams in the Regulatory Space, making it a pivotal regulatory affairs associate function in the life sciences job sector.
- eCTD Publishing: Lead the publishing and perform technical validation of eCTD for US submissions.
- Quality Review: Perform final technical quality review.
- Dispatch: Dispatch submissions (eCTD/CTD/NeeS/Paper) to the relevant authority or affiliate.
- Post-Submission: Manage post-submission processing, including receiving acknowledgements, capturing electronic receipt and metadata in RIM, and communicating submission receipt to key stakeholders.
- Correspondence Management: Capture and upload submissions-related correspondence (documentation, commitments) from health authorities.
Essential Qualifications and Expertise
Success in this regulatory affairs associate role requires a strong technical and regulatory foundation:
Minimum Qualifications
- Education: Bachelor’s degree, preferably in a Life science discipline, required with relevant experience in the pharmaceutical industry.
- Regulatory Knowledge (Mandatory): Mandatory in-depth knowledge of ICH and FDA guidelines for the US market.
- Publishing Systems: In-depth working knowledge of eCTD/CTD/NeeS/Paper types of submission and industry standard publishing systems.
- Language: Advanced level in the English language (written and verbal).
Preferred Qualifications/ Skills
- Experience and good knowledge of ICH guidelines and CTD Structure.
- Expertise with Publishing Tools like Liquent, DocuBridge, etc.
- Effective time management and organizational skills, communication skills, and 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 complex business challenges.
- Accelerate Your Career: Get hands-on experience, mentorship, and continuous learning opportunities.
- Thrive in a Values-Driven Culture: Join a place where courage, curiosity, and innovation fuel progress.
This regulatory affairs associate role offers a fast-track Genpact career focused on technical publishing excellence in the pharmaceutical field. If you possess mandatory ICH and FDA knowledge and seek a high-impact life sciences job in Mumbai, don’t miss this opportunity to join Genpact and build tomorrow together. Apply by the December 14, 2025 deadline.
