Genpact Released Job Openings On 26/08/2022.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,M.Pharma,M.Sc with experience for Manager – Regulatory Affairs Position.Complete Details for the Manager – Regulatory Affairs as follows.
Important Details :
- Location :Mumbai
- No of Vacancies:Not Disclosed
- Details of Salary:Not Disclosed
- Opening date for online Application: 26/08/2022
- 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
Related Job: Pfizer Looking For FRESHERS And Experienced
Job Description/Skills Required
- Leading project teams, ensuring maintenance of team records and process-related documentation i.e process maps, job aids, project trackers, checklists, etc.
- 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.
- It includes regulatory assessment; preparation and quality review of pre & post approval regulatory submission dossiers; and compliance activities
- Extensive experience in end-to-end life-cycle management of pharmaceuticals for EU, US and ROW markets for a vast range of therapeutic areas.
- Work on authoring CMC documentation for worldwide marketing of pharmaceutical products for initial registration and life-cycle management 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.
- Ability to lead client meetings and managing project governance.
- Deliver on agreed SLAs with clients at contract and account/ project level. Meet all monthly reporting/business metrics/KPIs requirements and manage internal control processes.
- Planning the project by understanding the client needs, channelizing appropriate resources, managing project deliverables and providing solutions in real time.
- Assess and communicate potential regulatory risks and propose mitigation strategies.
- Ability to prioritize & execute the project according to the project plan/ timelines/ schedules.
- Ensure established policies and procedures of the organization/client are followed and ensure compliance.
- Work with cross-functional teams to track and follow up outstanding documentation, coordinate on project status & reporting to stakeholders using different communication channels.