IT Solution Architect – Regulatory Affairs

Business Title: IT Solution Architect – Regulatory Affairs domain

Location: Malvern, PA (100% Remote Job: Need to be available EST)

Job Type: 6 months long term contract

Clients Update:

Resources have to be able to work with Regulatory IT and business partners on development of advanced AI/ML capabilities. They will need to understand Regulatory Affairs functions (product registrations, submission content management, label authoring and approval, regulatory intelligence, CMC, IDMP, etc) and the industry technologies used to support the functions (Snowflake, Denodo, NLP technologies, AWS AI/ML services, Calyx RIM, Veeva RIM, Docubridge, Documentum, API Gateways, Docuvera, LLMs, graph and vector DBs). The bar is high here because the resource needs to be the glue and architect across several experienced teams of AI/ML pioneers, Regulatory SMEs and Data Scientists with PhDs.

Clients are seeking an experienced Solution Architect to support Regulatory Strategy projects. The Regulatory Strategy Product Group delivers solutions which drive process orchestration, intelligent automation, advanced analytics and predictive modelling for Global Regulatory Affairs in Innovative Medicine.

The Regulatory Strategy team is US-based. Will consider resources local to NJ/PA or remote US (for resources with strong communication and organization skills in addition to the requirements outlined below).

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 client 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)

Skills & Experience 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, GCP 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.

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 is desirable