What are the responsibilities and job description for the Regulatory BA - REMOTE position at Sierra Solutions?
Job Summary
We are actively seeking an experienced Business Analyst (BA) to join a high-impact initiative supporting our client’s Regulatory group in the development of an Agentic GenAI platform for intelligent content creation. This is a dynamic opportunity to work at the intersection of Regulatory Affairs, Artificial Intelligence, and cutting-edge platform innovation in the Life Sciences sector.
Primary Responsibilities
We are actively seeking an experienced Business Analyst (BA) to join a high-impact initiative supporting our client’s Regulatory group in the development of an Agentic GenAI platform for intelligent content creation. This is a dynamic opportunity to work at the intersection of Regulatory Affairs, Artificial Intelligence, and cutting-edge platform innovation in the Life Sciences sector.
Primary Responsibilities
- Collaborate closely with business stakeholders, architects, and engineering teams across the US and UK to gather, document, and validate business and technical requirements for POCs.
- Drive the creation of requirements documentation, user stories, process flows, and other artifacts necessary to support platform development efforts.
- Work with the Regulatory team to deeply understand Regulatory registration content workflows and identify opportunities for AI-driven optimization.
- Serve as a bridge between the business and technical teams to ensure a clear understanding of the use cases, data requirements, and intended outcomes for GenAI-enabled solutions.
- Validate POC results by aligning outcomes against pre-defined requirements and user expectations, providing critical feedback for platform refinement.
- Maintain an informed perspective on AI platforms, infrastructure compatibility, and advancements in GenAI summarization and content generation tools.
- Support change management and adoption by translating complex GenAI concepts into tangible benefits for stakeholders.
- 5-10 years of experience as a Business Analyst, with a significant focus in Life Sciences, ideally within Regulatory Affairs.
- Proven track record of delivering business analysis in fast-paced, cross-functional environments.
- Strong familiarity with GenAI capabilities, including summarization, natural language generation, and intelligent document creation.
- Experience working with teams across global geographies, particularly the US and UK.
- Demonstrated ability to validate technical deliverables against functional business requirements.
- Familiarity with Regulatory content types such as Module 2 summaries, Clinical Overview documents, or eCTD submissions.
- Understanding of AI infrastructure and relevant platforms to support scalable deployment.
- AWS Certified AI Practitioner or similar certification highly desirable.
- Experience working in Agile or hybrid delivery models.
