Genpact Limited, a global leader in business process and technology management services, leverages the power of smarter processes, smarter analytics and smarter technology to help its clients drive intelligence across the enterprise. Genpacts Smart Enterprise Processes (SEP) framework, its unique science of process combined with deep domain expertise in multiple industry verticals, leads to superior business outcomes.
Post : Lead Associate - Regulatory Affairs-LIF007376
• 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.
• Contribute to draft Request for information and/ or Request for proposals for new client/ business opportunities. Provide inputs to project regulatory strategies by performing assessments of CMC changes, 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 ability to generate innovative solutions to problems and effectively collaborate with and communicate to key stakeholders.
• Demonstrated flexibility in responding to changing priorities, multi-tasking and dealing with unexpected events.
• Demonstrated effective leadership, communication, and interpersonal skills.
Bachelor's or master’s degree required in science, Pharmacy or related field (advanced degree preferred) with minimum 5 years of CMC RA experience
Qualification : M.Pharm, B.Pharm, M.Sc
Location : Mumbai
Industry Type : Pharma / Healthcare / Clinical research
End Date : 20th May, 2022
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