Mount Talent Consulting Pvt Ltd.Bengaluru, Karnataka, India
2 days ago
Job description
Domain lead - SME - Safety and Regulatory - BA offshore
Expert in Pharma domain’s multiple functions especially Regulatory and Safety
Well versed with business functions and tools used by industry
Able to create integrated solutions and able to address customer pain points
Able to draw process flows
Act 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 grooming
Drive 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 regulations
Provide 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 Safety
Have 10+ years of relevant experience
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Manager Regulatory • Bengaluru, Karnataka, India
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