Genpact Uregent Recruitment for Lead Associate – Regulatory Affairs-Apply Now

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.