Solution Architect Regulatory Strategy

Position-SOLUTION ARCHITECT: REGULATORY STRATEGY

Client-Health care Domain (Health care and Pharma Domain exp is mandatory

Architect Role experience is mandatory 12+ Yrs

Client is seeking an experienced Solution Architect to support Regulatory Strategy projects.

Location-Will consider resources local to NJ/PA or remote US

The Regulatory Strategy Product Group delivers solutions which drive process orchestration, intelligent automation, advanced analytics and predictive modeling for Global Regulatory Affairs in Innovative Medicine.

The Regulatory Strategy team is US-based

Excellent English and communication.

Must have Pharma and Regulatory experience.

10% travel
Roles and Responsibilities:

Partner with Product teams, CLIENT Technology Services and other architects to design scalable, flexible and supportable technical systems that drive business value in support of Regulatory Strategy and Intelligence
Develop architecture artifacts in collaboration with business and Tech product owners, lead engineers, platform owners, R&D Architecture, Information Security, Quality and Technology Services stakeholders.
Artifacts for each project include the business context diagram, process overview, data flow diagram, application architecture, data model overview, integration architecture, infrastructure architecture and ML and ML Ops architectures.
Responsible for architecture alignment to Regulatory, Enterprise and R&D technology strategies, patterns and standards.
Enable business at scale through scalable technologies applications, reusable integration patterns and intelligent automation.
Capture architecture and design information and decisions using Clients standard tools (Lean IX, SAXpress, Asset Management, Draw-IO, AMT, Confluence, MS Teams)
Education:

BA/BS degree in a technical, engineering or scientific field
AWS-Certified Solutions Architect certification required
AWS Well-Architected Framework certification desirable
AWS Certified Machine Learning Specialty certification desirable
Experience and Skills:

Required:

Understanding of Pharmaceutical Regulatory Affairs domain, capabilities, data, content and terminology
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)
Cloud native solution engineering experience covering compute, networking, storage, database and integrations

Proficiency in Deep Learning frameworks like TensorFlow, PyTorch, or similar tools for developing generative AI models.
Understanding of NLP, including large language models (LLMs), their training, and fine-tuning.
Knowledge of model training, evaluation, and optimization techniques.
Ability to tackle complex business challenges and provide actionable AI-based solutions.
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.