Genpact Hiring 2022 Bachelor’s or master’s degree for Lead Associate – Regulatory Affairs At India-Mumbai. Genpact Notification full details below..Interested and eligible candidates can Apply Now.
- Post Name: Lead Associate – Regulatory Affairs
- Qualification: Bachelor’s or master’s degree
Job Description: Genpact Hiring For Lead Associate – Regulatory Affairs !
Important Details :
- Post of date:28/07/2022
- Location: India-Mumbai
- Selection Process: The selection will be on the basis of Interview.
Roles and Responsibilities
Ensuring maintenance of team records and process-related documentation i.e process maps, job aids, project trackers, checklists, etc.
• Gather regulatory intelligence across globe for initial registration and life-cycle management for various modalities.
• Experience and understanding of CMC regulatory guidelines across globe. Regulated market guidelines knowledge is preferred.
• Responsible for interpreting CMC regulatory guidelines for assigned market in accordance with regulations, guidance and defined regulatory strategies
• Perform peer review.
• Ability to handle client meetings and managing project governance.
• Work with cross-functional teams to track and follow up outstanding system updates, changes proposed, coordinate on project status & reporting to stakeholders using different communication channels.
• 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 and managing project deliverables.
• 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.
• Contribute to draft Request for information and/ or Request for proposals for new client/ business opportunities. Provide inputs to project strategies by performing assessments, identifying global regulatory requirements and critically evaluate supporting documentation to assess acceptability and identify potential risks.
• Demonstrated oral and written communication skills and the ability to communicate issues in a succinct and logical manner. Strong listening skills.
• Demonstrated understanding of related fields (e.g., pharmaceutical manufacturing, analytical testing, and quality assurance).
• Demonstrated flexibility in responding to changing priorities, multi-tasking and dealing with unexpected events.
• Advanced knowledge of MS Office.
• Superior attentiveness to detail.
How to Apply :
Step 1: Click on below link and you will be redirected to Career Page of Recruiting Company or Career portal.
Step 2. Register on Career Page of the Company or Career Portal by giving log in credentials and other personal or education details .
Step 3.Upon successful registration .User need to log in with credentials.
Step 4.Once logged in, User need to fill the all relevant personal ,educational , Work experience details ,attach resume and submit application form.