ph3Principal Advisory Consultant - Regulatory Affairs: /h3 pNNIT 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. /p pTo 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. /p pYou will play a key role in shaping and growing our Regulatory Affairs advisory services with focus on structured data, interoperability, and digital regulatory transformation. /p h3Your responsibilities: /h3 pYou 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. /p ul li60% delivering consultancy projects in advisor, project lead, architect, or engagement delivery lead roles with focus on FHIR enabled regulatory solutions /li li20% business development, presales, and thought leadership activities within Regulatory Affairs and interoperability /li li10% development of consultancy offerings, delivery methodologies,



and training materials related to FHIR and digital regulatory transformation /li li5% development and delivery of RFP responses to secure new and expanded client engagements /li li5% coaching and mentoring consultants across all levels within the Regulatory Affairs team /li /ul pIn your client engagements, you will: /p ul liAdvise on implementation and governance of FHIR standards in regulatory contexts /li liSupport integration of FHIR with RIM systems, IDMP, and structured content management platforms /li liTranslate integral regulatory requirements into compliant, data driven and interoperable solutions /li liAct as trusted advisor to senior stakeholders in pharmaceutical, biotech, and medtech organizations /li liDrive alignment between business, regulatory, and IT functions /li /ul h3Your qualifications and experience: /h3 ul liBachelor degree or equivalent in Pharmaceutical Compliance, Regulatory Affairs, Life Sciences, or related discipline /li liSignificant experience in Regulatory Affairs within a pharmaceutical, biotech, or medtech company or as a consultant /li liProven consulting experience within a recognized consultancy serving life sciences clients /li liStrong knowledge of FHIR and its application in healthcare data exchange and regulatory use cases /li liExperience with global regulatory frameworks including EMA and FDA /li liDemonstrated experience in sales and business development within a consulting environment /li liStrong stakeholder management skills and ability to engage clients, partners,



and vendors /liliExcellent documentation, communication, and interpersonal skills in English /li /ul h3Preferred requirements: /h3 ul liMaster degree in Pharmaceutical Compliance, Regulatory Affairs, or related field /li liExperience with RIM systems and IDMP /li liKnowledge of data governance and Master Data Management principles /li liExperience bringing new products to market in regulated environments /li liPeople management experience and track record of leading complex multi stakeholder projects /li liProject management experience with consistent on time and on budget delivery /li liFluency in an additional European language such as German, Danish, Italian, Spanish, or French /li liA dynamic workplace with strong professional community and focus on collaboration /li liOpportunity to work with leading life sciences companies across Europe /li liInfluence on strategic direction and growth of our Regulatory Affairs advisory services /li liCompetitive salary, bonus, and benefits package /li liClear personal development model supporting your long term career goals /li liMulticultural environment with an open and professional working culture /li /ul pWe 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 /p pFluency in oral and written English is a must. A second language (Danish, German, Italian, Spanish or French) is desired but not essential. /p pTravel must be expected, but will be kept to necessary business trips (10%). /p /p #J-18808-Ljbffr

📌 Principal Consultant (España)
🏢 NNIT
📍 España