Regulatory Affairs SME

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