Regulatory Affairs Job Opportunity at Genpact | Pharmacy Graduates | Apply Now
If you are looking for Pharma Jobs in the regulatory sector, this Regulatory Affairs job opportunity at Genpact could be the perfect next step in your career. Genpact is hiring for the position of Regulatory Affairs Specialist – Assistant Manager/Manager (CMC and Labelling). This opportunity is ideal for candidates with experience in regulatory compliance, dossier preparation, and CMC documentation. Professionals with B.Pharmacy, M.Pharmacy qualifications who are searching for Pharma Jobs in regulatory affairs can explore this excellent Regulatory Affairs job in a technology-driven global organization.
- Job Position: Regulatory Affairs Specialist
- Location: Mumbai
About the Company
Genpact is an advanced technology services and solutions company that delivers lasting value for leading enterprises globally. Through deep business knowledge, operational excellence, and cutting-edge solutions, Genpact helps companies across industries stay ahead in a rapidly evolving digital landscape.
The company is known for its focus on innovation through AI, data, and advanced technology solutions. Genpact’s AI Gigafactory accelerator is an example of how the organization scales digital innovation and transformation for global enterprises. Professionals looking for Pharma Jobs and a Regulatory Affairs job in a technology-driven environment can find exciting opportunities at Genpact.
Key Responsibilities
- Responsible for handling client-based requirements for new product registrations, pre-approval, and post-approval submissions.
- Compilation and submission of the technical documents for Consumer health care products within stipulated timelines.
- Authoring of Quality Overall Summaries (QOS) and Module 3 CTD sections with reviewed and compliant data.
- Responsible for the writing of CMC quality documents for the dossier and/or the entire module 3 from raw data.
- Review and evaluation of existing quality documentation and assessment of required updates during Project Renewals.
- Preparation of Quality Overall Summaries (QOS).
- Knowledge of review and assessment of manufacturing, analytical, validation, and stability documents.
Qualifications
- B. Pharmacy
- M. Pharmacy
