Principal Advisory Consultant - Regulatory Affairs:
NNIT is one of the world’s leading consultancies serving the life sciences industry globally. For more than twenty years, we have enabled our customers to achieve their business goals through digitalization within Quality Assurance, Regulatory Affairs, Clinical, Pharma Production and Laboratory processes.
To further strengthen our Regulatory Affairs team, we are looking for a Principal Advisory Consultant with significant Regulatory Affairs experience and strong expertise within FHIR and healthcare interoperability standards.
You will play a key role in shaping and growing our Regulatory Affairs advisory services with focus on structured data, interoperability, and digital regulatory transformation.
Your responsibilities:
You will join our Regulatory Affairs team as a Principal Advisory Consultant. You will contribute to forming the strategy for growing the Regulatory Affairs business unit with focus on FHIR and structured data, and you will be co responsible for executing this strategy through business development, thought leadership,
and client delivery.
60% delivering consultancy projects in advisor, project lead, architect, or engagement delivery lead roles with focus on FHIR enabled regulatory solutions
20% business development, presales, and thought leadership activities within Regulatory Affairs and interoperability
10% development of consultancy offerings, delivery methodologies, and training materials related to FHIR and digital regulatory transformation
5% development and delivery of RFP responses to secure new and expanded client engagements
5% coaching and mentoring consultants across all levels within the Regulatory Affairs team
In your client engagements, you will:
Advise on implementation and governance of FHIR standards in regulatory contexts
Support integration of FHIR with RIM systems, IDMP, and structured content management platforms
Translate integral regulatory requirements into compliant, dat
📌 Principal Consultant (España)
🏢 NNIT
📍 España
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