Regulatory Affairs Job at Genpact | Apply Now
Genpact, a global leader in advanced technology services and digital transformation, is inviting applications for the role of Assistant Manager/Manager in Regulatory Affairs, CMC, and Labelling. Based in Mumbai, this position is a cornerstone for those pursuing a high-impact Regulatory Affairs Job. You will be joining Genpact’s “AI Gigafactory” ecosystem, where industry-first accelerators and agentic AI are redefining how global enterprises manage complex regulatory landscapes. If you are looking to elevate your Genpact Career, this role offers the chance to drive transformation in Chemistry, Manufacturing, and Controls (CMC) while leveraging cutting-edge digital solutions.
- Job Position: Regulatory Affairs Specialist
- Location: Mumbai, Maharashtra, India
About the Company
Genpact is a powerhouse of 140,000+ bold thinkers who provide operational excellence to leading enterprises worldwide. The company is currently leading the charge in scaling AI models to solve real-world business challenges at scale. A Genpact Career is built on the foundations of curiosity, courage, and incisiveness, fostering an inclusive environment where ideas fuel progress.
Key Responsibilities
In this Regulatory Affairs Job, you will be responsible for navigating the technical complexities of consumer healthcare products and pharmaceutical dossiers.
- Dossier Compilation: Handle client requirements for new product registrations, encompassing both pre-approval and post-approval submissions.
- CTD Module Management: Author Quality Overall Summaries (QOS) and Module 3 Common Technical Document (CTD) sections using reviewed, compliant data.
- CMC Documentation: Write CMC quality documents from raw data, ensuring the entire Module 3 is technically sound and accurate.
- Project Renewals: Review and evaluate existing quality documentation to assess and implement necessary updates during project renewal cycles.
- Technical Assessment: Conduct thorough reviews of manufacturing, analytical, validation, and stability documents to ensure total regulatory compliance.
Qualifications and Skills Required
Genpact is seeking candidates who combine pharmaceutical domain expertise with strong analytical capabilities.
- Education: Minimum qualification includes a B.Sc., or M.Sc. degree.
- Domain Expertise: Deep knowledge in CMC and compliance services is essential for this managerial level Regulatory Affairs Job.
- Technical Skills: Proficiency in assessing manufacturing and validation data, along with a firm grasp of CTD requirements.
- Operational Excellence: The ability to compile technical documents within stipulated timelines while maintaining high data integrity.
- Digital Fluency: A desire to work at the intersection of regulatory domain knowledge and digital technology to drive process improvements.
Choosing a Regulatory Affairs Job at Genpact means positioning yourself at the forefront of the digital revolution in healthcare compliance. This Genpact Career path allows you to transition traditional CMC expertise into a tech-driven framework, making your work faster, smarter, and more impactful. As enterprises globally struggle with the speed of change, your ability to author Module 3 CTD sections and manage QOS within Genpact’s AI-enhanced ecosystem will be a critical asset. If you have a background in Pharmacy or Life Sciences and a passion for operational excellence, this Mumbai-based role is your gateway to shaping the future of work.
