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Genpact

Specialist - Regulatory Affairs - Operations 4A

Job · Full-timeIn OfficeMumbai1-2 years1 opening

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About this role

Genpact is hiring for Specialist - Regulatory Affairs - Operations 4A in Mumbai. This opening was published by Genpact on their official careers board (Workday) on 25 August 2026 and was confirmed live on 14 September 2026. Job details • Company: Genpact • Role: Specialist - Regulatory Affairs…

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Skills you'll use

Power BISAPCommunicationQuality Control

What you'll do

Responsible for implementing CMC regulatory strategies for assigned pharmaceutical products in accordance with global regulations, guidance and defined regulatory strategies along with the preparation and review of information required for development of regulatory CMC dossiers for commercial products of small molecules/ pharma, large molecules/ biologicals, etc.
Work on authoring CMC documentation for worldwide marketing of pharmaceutical products for initial registration and life-cycle management submissions under direction of team scientists.
Experience in reviewing scientific information to assess technical merits and suitability of scientific rationale to ensure information is presented clearly and conclusions are adequately supported by data.
Able to prioritize & execute the project according to the project plan/timelines/schedules.
Work with cross-functional teams to track and follow up outstanding documentation, coordinate on project status & reporting to stakeholders using different communication channels.
Understanding of job responsibilities & processes of cross-functional teams, manufacturing sites, Quality Assurance, Quality control, etc. Prior experience in these departments is preferable.
Experience in RA/ QA/ QC system and tools like SAP, documentum, Veeva, LIMS, spotfire, Power BI, etc is preferrable.
Demonstrated oral and written communication skills and the ability to communicate issues in a succinct and logical manner. Strong listening skills.
Demonstrated understanding of related fields (e.g., pharmaceutical manufacturing, analytical testing, and quality assurance).
Ability to generate innovative solutions to problems and effectively collaborate with and communicate to key stakeholders.

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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