Offer summary

Qualifications:

8+ years of experience in pharma or life sciences IT, with at least 3+ years in Regulatory Affairs systems., Proven experience in designing enterprise-scale IT architectures using cloud platforms., Hands-on experience with GenAI or NLP technologies applied in the pharma or healthcare context., Strong understanding of regulatory standards and systems such as Veeva Vault RIM, IDMP, and eCTD..

Key responsibilities:

Architect and design IT solutions for global Regulatory Affairs functions.

Collaborate with business stakeholders to translate requirements into technology solutions.

Lead architectural governance for regulatory systems and ensure compliance with GxP standards.

Provide mentorship and technical guidance to development and support teams.

Job description

Architect and design IT solutions tailored to global Regulatory Affairs functions, including submissions, registration tracking, labeling, and IDMP compliance.
Collaborate with business stakeholders to understand requirements and translate them into scalable, compliant, and efficient technology solutions.
Lead end-to-end architectural governance for regulatory systems, including integrations with RIM, DMS, and Health Authority gateways.
Design and optimize Cloud-native data pipelines for regulatory data ingestion, transformation, and analytics (e.g., using Azure, AWS, or GCP).
Develop and guide implementation of GenAI solutions (e.g., document summarization, narrative generation, intelligent labeling) for regulatory use cases.
Ensure data integrity, GxP compliance, and audit readiness across all regulatory systems and data flows.
Evaluate and select technologies and vendors that align with enterprise architecture standards and future vision.
Collaborate with QA, validation, and compliance teams to support system validation and lifecycle management under regulatory frameworks.
Provide thought leadership on emerging technologies (e.g., AI/ML, LLMs, NLP) and their relevance to the evolving regulatory landscape.
Lead or support integration of external partner systems and health authority interfaces (e.g., EMA, FDA, PMDA).
Work closely with Data Governance teams to ensure master data and metadata management align with IDMP and xEVMPD standards.
Drive the adoption of modern APIs and microservices to support modular, reusable architectures.
Contribute to or lead architectural reviews, risk assessments, and remediation planning.
Provide mentorship and technical guidance to development and support teams.
Exposure to DevOps pipelines and practices (CI/CD, containerization, IaC) is a plus.

8+ years of experience in pharma or life sciences IT, with at least 3+ years in Regulatory Affairs systems.
Proven experience in designing enterprise-scale IT architectures using cloud platforms.
Hands-on experience with GenAI or NLP technologies applied in the pharma or healthcare context.
Strong understanding of regulatory standards and systems (e.g., Veeva Vault RIM, IDMP, eCTD).
Excellent communication, stakeholder engagement, and cross-functional leadership skills.

Required profile