Principal Consultant - Regulatory Affairs

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.

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:

Essential requirements:

• 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 global 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

Why join NNIT

• 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

What’s next?

If you recognize yourself in this role, we’ll be looking forward to hearing from you. Please apply with a full resume and references that describe your abilities with regard of taking this leading role in NNIT’s Lab Consulting team.