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Genpact

Specialist - Regulatory Affairs - Operations 4B

Job · Full-timeIn OfficeHyderabad1-2 years1 opening

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About this role

Genpact is hiring for Specialist - Regulatory Affairs - Operations 4B in Hyderabad. This opening was published by Genpact on their official careers board (Workday) on 13 August 2026 and was confirmed live on 14 September 2026. Job details • Company: Genpact • Role: Specialist - Regulatory Affairs…

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What you'll do

Support through a number of regulatory functions specific to post-approval, lifecycle management capacities which includes –
Provide scientific inputs and actively involved in RA CMC strategic discussions
Monitor assumptions, risks and dependencies
Manage and oversee regulatory post approval Chemistry, Manufacturing and Controls (CMC) changes involving deliverables such as:
Provide of regulatory evaluation of change control (affected countries, data/documentation requirements per country, change category per country and regulatory procedure per country) and regulatory strategy
Provide tracking list and review documentation
Dispatch final documentation package to Local Regulatory Affairs (LRA) in affected countries
Monitor timely submission and approval in affected countries
Manage and coordinate responses to health authority questions
Overall planning of all CMC regulatory changes per product together with relevant interfaces

Who can apply

Bachelors - Health Administration, Bachelors - Healthcare, Bachelors - Pharmacy, Masters - Public Health, Masters - Regulatory Affairs
Certified Compliance Officer (CCO) - VskillsVskills, Certified Public Accountant (CPA) - Perfekt SzolnokPerfekt Szolnok, Certified Regulatory and Compliance Professional (CRCP) - JSS UniversityJSS University, Certified Regulatory Compliance Manager (CRCM) - The International Association of Risk and Compliance Professionals (IARCP)The International Association of Risk and Compliance Professionals (IARCP)
Pharmaceutical Regulatory Affairs
English (Required)
Language Proficiency -
Additional Job Location -

Perks & benefits

Lead AI-powered transformation – Drive innovation and solve real-world business challenges that matterMake an impact – Help global enterprises solve business challenges that matterAccelerate your career – Gain hands-on experience, mentorship, and world-class learning opportunities to stay aheadWork with the best – Join 140,000+ bold thinkers and problem-solvers who push boundaries every dayThrive in a values-driven culture – Our courage, curiosity, and incisiveness - built on a foundation of integrity and inclusion - allow your ideas to fuel progressCome join the 140,000+ coders, 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.

About Genpact

Specialist - Regulatory Affairs - Operations Ready to turn bold ideas into real-world impact? At Genpact, we don’t just adapt to change, we lead it. AI and digital innovation are transforming the way businesses work, and we’re at the forefront of it. Genpact’s AI Gigafactory, our industry-first…

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