Regulatory Affairs Manager- SME

1 day ago


bangalore, India Mount Talent Consulting Pvt Ltd. Full time

Domain lead - SME - Safety and Regulatory - BA offshoreExpert in Pharma domain’s multiple functions especially Regulatory and SafetyWell versed with business functions and tools used by industryAble to create integrated solutions and able to address customer pain pointsAble to draw process flowsAct as Technical Product Owner for global regulatory systems and solutions, ensuring alignment with business goals and compliance requirements.Gather, analyze, and document business requirements from regulatory stakeholders across global regions, ensuring clarity and completeness.Facilitate workshops, requirement-gathering sessions, and backlog groomingDrive solution design discussions, ensuring integration with existing regulatory, safety and submission management platforms.Ensure adherence to pharmaceutical regulatory frameworks (e.g., FDA, EMA, ICH) and compliance with data integrity and GxP standards.Have knowledge of FDA, EMA and other agency’s rules and regulationsProvide thought leadership on digital tools and process optimization in the global regulatory affairs space as well as Safety signal identification and assessment.Be the go-to person for customers and Account team for any functional knowledge on Regulatory and SafetyHave 10+ years of relevant experience



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