Genpact Released Job Openings On 14/05/2022.Genpact (NYSE: G) is a global professional services firm focused on delivering digital transformation for our clients, putting digital and data to work to create competitive advantage. We do this by integrating lean principles, design thinking, analytics and digital technologies with our domain and industry expertise to deliver disruptive business outcomes – an approach we call Lean DigitalSM..Eligibility Criteria / Educational Qualification, Official Notification, Apply Online Form Link & Other Relevant Details for Genpact Recruitment 2022 are provided below. Interested and eligible candidates can submit application along with resume.
Genpact Recruiting B.Pharma,B.Sc Candidates with 01+ Years Experience for DG – Lead Associate – Regulatory Affairs Position.Complete Details for the DG – Lead Associate – Regulatory Affairs as follows.
Important Details :
- Location :Mumbai
- No of Vacancies:Not Disclosed
- Details of Salary:Not Disclosed
- Opening date for online Application: 14/05/2022
- Mode of application :Online
- How To Apply: At the End of the Article We Have Provided Source Link,Please Go through that and Follow Necessary Steps
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Job Description/Skills Required
The Role demands for a highly qualified professional who should have CMC experience under regulatory affairs domain. Lead Associate will be responsible for all the activities related to –
- Provide input to project regulatory strategies by performing assessments of CMC changes, identifying global regulatory requirements and critically evaluating supporting documentation to assess acceptability and identify potential risks.
- Execute regulatory strategies by leading the development, authoring and review of CMC submission components and documentation to support post-approval supplements, annual reports, registration renewals and responses to health authority questions per established business processes and systems.
- Collaborate closely with MMD and partners to support compliant execution of organizational change and conduct all activities with an unwavering focus on regulatory conformance.
- Assess and communicate potential regulatory risks and propose mitigation strategies.
- Deliver all regulatory results for assigned products across the product lifecycle
- Identify and communicate potential regulatory issues to GRACS CMC, as needed
- Demonstrated understanding of related fields (e.g., pharmaceutical manufacturing, analytical testing, and quality assurance).
- Proven ability to generate innovative solutions to problems and effectively work with and communicate to key partners.
- Proven flexibility in responding to changing priorities or taking care of unexpected events.
- Capability to handle multiple priorities and balance work to achieve business goals.