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Regulatory Affairs Manager- SME

Regulatory Affairs Manager- SME

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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