Solution Architect, Regulatory Strategy

Solution Architect, Regulatory Strategy
Experience and Skills:
Required:
Understanding of Pharmaceutical Regulatory Affairs domain, capabilities, data, content and
terminology. Experience with medical writing and authoring processes and technologies will also
be considered.
5+ years of experience as a Solution Architect in Pharmaceutical development
5+ years of experience in integration design and operationalization (REST APIs, Kafka, ETL, data
pipeline design, API gateways, data streaming)
5+ years of experience working with content management platforms and structured RDBMS
5+ years experience architecting and deploying cloud-native, scalable solutions on AWS, Google Cloud Platform
and/or Azure for data capture, advance analytics and intelligent automation.
Experience architecting regulated systems (GxP, HIPAA, GDPR, etc)
Experience architecting workflow automation solutions leveraging generative AI and/or machine
learning to deliver operational efficiencies
Cloud native solution engineering experience covering compute, networking, storage, database
and integrations

Proficiency in frameworks such as TensorFlow, PyTorch, or similar tools for incorporating
generative AI models and capabilities into agentic, workflow automation and analytic solutions
Understanding of large language models (LLMs), their training, and fine-tuning.
Knowledge of model training, evaluation, optimization and data privacy and security
management when leveraging public LLMs
Ability to tackle complex business challenges and provide actionable AI-based solutions.
Strong written and verbal communication skills (ability to communicate in the language of the
audience effectively)
Experience leading technical conversations, working to remove ambiguity, drive consensus and
decisions across stakeholders
Proven ability to understand and articulate business requirements, direction, and initiatives
Experience surfacing technical requirements and contributing to IT product roadmaps
Excellent oral and written communication skills including the ability to translate and transform
complex topics into concise architectural diagrams and presentations.
Strong ability to build and manage relationships at various levels, both inside and outside an
organization.
Proven track record of designing robust, highly available, scalable and flexible solutions that
serve a multi-national user and Health Authority community.