Über Nikolas
I help Life Sciences organizations modernize Regulatory Affairs and R&D — turning compliance into a strategic advantage.
With more than 20 years of experience across pharma, biotech, and medtech, I bridge strategy, data, and leadership to create measurable transformation. Clients value my ability to translate complex regulatory and R&D challenges into practical, forward-looking solutions.
My focus areas include:
- Regulatory Transformation: Operating model design, digital enablement, and process simplification
- Digital R&D Strategy: AI-driven regulatory intelligence, data governance, and IDMP / RIM optimization
- Executive Advisory: Defining roadmaps, shaping transformation portfolios, and aligning leadership
I’ve led high-visibility projects for global Life Sciences companies — working directly with senior decision-makers to design future-ready operating models, improve data maturity, and accelerate digital impac
Englisch
Muttersprachlich oder zweisprachig
Deutsch
Muttersprachlich oder zweisprachig
Vor Ort möglich
Zurich (bis zu 50 km)
Projekt- und Berufserfahrung
- Pharmaceutical CompanyLead Consultant – Regulatory Affairs Strategy & Operating Model TransformationPHARMAZEUTISCHE INDUSTRIEApril 2025 - Juni 2025 (2 Monate)Led a full-scale assessment of the global Regulatory Affairs organization for a mid-sized pharma group, focusing on structure, governance, data management, and digital enablement.Delivered a comprehensive Current State Assessment, Gap Analysis, and Target Operating Model options to guide transformation.Defined roadmap and quick-win initiatives to enhance RIM adoption, data quality, and workload visibility.Worked directly with senior leadership to align transformation priorities and organizational maturity goals.Produced executive-level deliverables integrating benchmarking, best practices, and stakeholder insights.
- Global Consumer Health CompanyLead Consultant – Regulatory Intelligence & AI StrategyJanuar 2025 - März 2025 (2 Monate)Designed an AI-driven framework for predictive regulatory intelligence to enhance global compliance readiness and early-signal detection.Defined data architecture, metadata model, and governance for integrating internal and external information sources.Developed a proof-of-concept prototype using NLP and analytics to automate insights generation and risk anticipation.Combined strategic design with hands-on blueprinting for lean, scalable regulatory operations across markets.Delivered an implementation roadmap connecting business strategy, digital capabilities, and change adoption.
- Multinational Life Sciences ClientsRegulatory & Digital R&D TransformationPHARMAZEUTISCHE INDUSTRIEFebruar 2018 - Oktober 2025 (7 Jahre und 9 Monate)Delivered strategic advisory and transformation programs for leading life sciences clients, covering Regulatory Affairs, R&D, and Manufacturing.Supported RIM assessments, digital adoption programs, and data integration initiatives across global organizations.Defined business cases and operating models to modernize regulatory structures and improve data visibility.Acted as Subject Matter Expert for AI, IDMP, and regulatory data management.Developed frameworks highlighting the business value of Regulatory Affairs within the R&D digital ecosystem.
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Ausbildung und Abschlüsse
- PharmacistThe University of Freiburg1996Pharmacist (State Examination)