Genpact – Specialist Regulatory Affairs Vacancy in Mumbai
Genpact is recruiting for a Specialist – Regulatory Affairs role at its Mumbai, Maharashtra office. The role focuses on CMC regulatory affairs, with responsibility for preparing regulatory dossiers and managing submission lifecycles. It is a full-time role with a hybrid working arrangement.
Job Details
| Particulars | Details |
| Company | Genpact |
| Position | Specialist – Regulatory Affairs |
| Department | Regulatory Affairs |
| Location | Mumbai, Maharashtra, India |
| Employment Type | Full-time |
| Work Mode | Hybrid |
Job Responsibilities
- Implement CMC regulatory strategies for the products assigned to you in accordance with global regulations and company-defined procedures.
- Prepare and review information for regulatory CMC dossiers for commercial products, including small molecules, large molecules, and biologicals.
- Author CMC documentation for global marketing submissions and lifecycle management, in accordance with input from team scientists.
- Review scientific data to assess technical merit and ensure the information is clearly presented and properly supported by the data.
- Prioritise and deliver projects in accordance with the plans and timelines defined.
- Work with cross-functional teams to track documentation, ensure deliverables, and report on project status.
- Understand the processes of interdepartmental teams, manufacturing sites, Quality Assurance, and Quality Control.
- Be involved in departmental improvement activities, including system updates and maintenance of SOPs and internal guidelines.
- Work with stakeholders to identify issues and work out solutions.
- Adapt to changing priorities, manage multiple tasks, and deal with the unexpected.
Required Skills and Competencies
- Knowledge of pharma manufacturing, analytical testing, and QA is required.
- Experience with Regulatory Affairs, Quality Assurance, or Quality Control systems and tools, such as SAP, Documentum, Veeva, LIMS, Spotfire, and Power BI, is preferred.
- Good written and verbal communication skills.
- Ability to communicate the issues clearly and logically.
- Proficiency in MS Office.
- Attention to detail.
- Leadership and interpersonal skills.
- Ability to work with cross-functional teams and manage project schedules.
- Flexibility to deal with changing priorities and unforeseen circumstances.
Benefits of Working at Genpact
Genpact offers the opportunity to work on technology, automation, and digital innovation projects for global clients.
- Hands on in transformation and digital innovation projects.
- Mentorship and continuous learning.
- Career development opportunities.
- Collaboration with global teams.
- A culture of integrity, inclusion and innovation.
How to Apply
Interested candidates should apply online via the Genpact careers listing on LinkedIn.
Apply Online: https://www.linkedin.com/jobs/view/4489492025/
Note: Genpact do not charge any fees for job applications. Candidates should not be required to pay for application processing, training, equipment or any part of the recruitment process.
Job Summary
| Company | Position | Location | Work Mode | Employment Type |
| Genpact | Specialist – Regulatory Affairs | Mumbai, Maharashtra | Hybrid | Full-time |