IT Solution Architect – Regulatory Affairs

Accuro; Malvern (Chester County); Remote; USD 90,000 - 150,000; Full time

Job summary

Join a forward-thinking company as an IT Solution Architect focused on Regulatory Affairs. This role offers the chance to collaborate with experts in AI/ML while designing scalable and flexible systems that drive business value. You will work on advanced analytics and intelligent automation to support Regulatory Strategy projects. Ideal candidates will possess strong communication skills and a deep understanding of the Pharmaceutical domain. This is a unique opportunity to contribute to innovative solutions that impact the industry. If you are passionate about technology and regulatory affairs, this position is designed for you.

Qualifications

• 5+ years as a Solution Architect in Pharmaceutical development.
• Strong understanding of Regulatory Affairs and AI/ML technologies.
• Experience with cloud-native solutions on AWS, GCP, or Azure.

Responsibilities

• Design scalable systems for Regulatory Strategy and Intelligence.
• Develop architecture artifacts in collaboration with stakeholders.
• Capture architecture decisions using standard tools.

Skills

Solution Architecture

Pharmaceutical Regulatory Affairs

Integration Design

Cloud-Native Solutions

Deep Learning Frameworks

NLP Techniques

Communication Skills

Data Pipeline Design

Technical Leadership

Relationship Management

Education

BA/BS in Technical Field

AWS-Certified Solutions Architect

AWS Certified Machine Learning Specialty

Tools

Lean IX

SAXpress

Draw-IO

Confluence

MS Teams

Job description

IT Solution Architect – Regulatory Affairs

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.
• 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 Certified Machine Learning Specialty certification is desirable.

Seniority level

Mid-Senior level

Employment type

Contract

Job function

Analyst and Other

Industries

Staffing and Recruiting