Principal Consultant - Regulatory Affairs

Principal Advisory Consultant - Regulatory Affairs:

NNIT is one of the world's leading consultancies serving thelife sciences industry globally. For more than twenty years, we have enabledour customers to achieve their business goals through digitalization withinQuality Assurance, Regulatory Affairs, Clinical, Pharma Production andLaboratory processes.
To further strengthen our Regulatory Affairs team, we arelooking for a Principal Advisory Consultant with significant Regulatory Affairsexperience and strong expertise within FHIR and healthcare interoperabilitystandards.
You will play a key role in shaping and growing ourRegulatory Affairs advisory services with focus on structured data,interoperability, and digital regulatory transformation.

Your responsibilities:

You will join our Regulatory Affairs team as a PrincipalAdvisory Consultant. You will contribute to forming the strategy for growingthe Regulatory Affairs business unit with focus on FHIR and structured data,and you will be co responsible for executing this strategy through businessdevelopment, thought leadership, and client delivery.

On average you will split your time:

• 60% delivering consultancy projects in advisor, projectlead, architect, or engagement delivery lead roles with focus on FHIR enabledregulatory solutions
• 20% business development, presales, and thought leadership activities withinRegulatory Affairs and interoperability
• 10% development of consultancy offerings, delivery methodologies, andtraining materials related to FHIR and digital regulatory transformation
• 5% development and delivery of RFP responses to secure new and expandedclient engagements
• 5% coaching and mentoring consultants across all levels within the RegulatoryAffairs team

In your client engagements, you will:

• Advise on implementation and governance of FHIR standards inregulatory contexts
• Support integration of FHIR with RIM systems, IDMP, and structured contentmanagement platforms
• Translate global regulatory requirements into compliant, data driven andinteroperable solutions
• Act as trusted advisor to senior stakeholders in pharmaceutical, biotech, andmedtech organizations
• Drive alignment between business, regulatory, and IT functions

Your qualifications and experience:

Essential requirements:

• Bachelordegree or equivalent in Pharmaceutical Compliance, Regulatory Affairs, LifeSciences, 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 lifesciences clients
• Strong knowledge of FHIR and its application in healthcare data exchange andregulatory use cases
• Experience with global regulatory frameworks including EMA and FDA
• Demonstrated experience in sales and business development within a consultingenvironment
• Strong stakeholder management skills and ability to engage clients, partners,and vendors
• Excellent documentation, communication, and interpersonal skills inEnglish

Preferred requirements:

• Master degree in Pharmaceutical Compliance, RegulatoryAffairs, 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 multistakeholder 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 andfocus on collaboration
• Opportunity to work with leading life sciences companies across Europe
• Influence on strategic direction and growth of our Regulatory Affairsadvisory services
• Competitive salary, bonus, and benefits package
• Clear personal development model supporting your long term career goals
• Multicultural environment with an open and professional workingculture

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

Fluency in oral and written English is a must. Asecond language (Danish, German, Italian, Spanish or French) is desired but notessential.

Travel must beexpected,but will be kept to necessary business trips (<10%).

What's next?
If you recognize yourself in this role, we'll be looking forward to hearingfrom you. Please apply with a full resume and references that describe yourabilities with regard of taking this leading role in NNIT's Lab Consultingteam.

Apply now and make your mark!