Regulatory Affairs Manager- SME
4 weeks ago
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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Regulatory Affairs Executive
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Regulatory Affairs
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Head- Regulatory Affairs
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Technical Product Owner
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Regulatory Affairs Manager
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Regulatory Affairs
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Senior Regulatory Affairs Specialist
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Regulatory Affairs Data Analyst
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