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 global regulatory requirements into compliant, data driven and interoperable solutions

Act as trusted advisor to senior stakeholders in pharmaceutical, biotech, and medtech organizations

Drive alignment between business, regulatory, and IT functions

Your qualifications and experience:

Bachelor degree or equivalent in Pharmaceutical Compliance, Regulatory Affairs, Life Sciences, or related discipline

Significant experience in Regulatory Affairs within a pharmaceutical, biotech, or medtech company or as a consultant

Proven consulting experience within a recognized consultancy serving life sciences clients

Strong knowledge of FHIR and its application in healthcare data exchange and regulatory use cases

Experience with general regulatory frameworks including EMA and FDA

Demonstrated experience in sales and business development within a consulting environment

Strong stakeholder management skills and ability to engage clients, partners,



and vendors

Excellent documentation, communication, and interpersonal skills in English

Preferred requirements:

Master degree in Pharmaceutical Compliance, Regulatory Affairs, or related field

Experience with RIM systems and IDMP

Knowledge of data governance and Master Data Management principles

Experience bringing new products to market in regulated environments

People management experience and track record of leading complex multi stakeholder projects

Project management experience with consistent on time and on budget delivery

Fluency in an additional European language such as German, Danish, Italian, Spanish, or French

A dynamic workplace with strong professional community and focus on collaboration

Opportunity to work with leading life sciences companies across Europe

Influence on strategic direction and growth of our Regulatory Affairs advisory services

Competitive salary, bonus, and benefits package

Clear personal development model supporting your long term career goals

Multicultural environment with an open and professional working culture

We are hiring into our European team in the following countries: UK and Europe - the role can be based in any European country where NNIT has an office location - Denmark, Germany, Ireland, Switzerland, Italy, Spain

Fluency in oral and written English is a must. A second language (Danish, German, Italian, Spanish or French) is desired but not essential.

Travel must be expected, but will be kept to necessary business trips ( #J-18808-Ljbffr

📌 Principal Consultant (Madrid)
🏢 NNIT
📍 Madrid