About Mette Linnea Jensen
I am a Regulatory Affairs professional with extensive experience supporting regulatory activities within EU-regulated clinical and pharmaceutical environments. I contribute with structure, clarity and a calm, solution-oriented approach in complex regulatory settings, helping organisations navigate regulatory requirements with confidence.
Through Nordic Regulatory Bridge, I provide ad hoc regulatory advisory support to organisations within clinical research and life sciences. My work focuses on regulatory frameworks, compliance considerations and practical navigation of regulatory requirements, translating complexity into clear actions and realistic timelines.
I hold a Master of Science in Engineering (Protein Chemistry) and a Bachelor of Science in Engineering (Chemistry), and I have more than 15 years of experience across the regulatory landscape. I am known for bringing overview, consistency and trust to cross-functional collaboration, and for supporting progress even when timelines are tight or regulatory complexity is high.
Nordic Regulatory Bridge offers flexible, short-term or interim regulatory support, tailored to organisational needs during periods of transition, increased regulatory demand or change.
— 15 years of experience
With more than 15 years of experience across the regulatory landscape, I have supported regulatory submissions, compliance activities and cross-functional collaboration within EU-regulated clinical and pharmaceutical environments. My experience spans both sponsor and advisory contexts, with a strong focus on structure, quality and practical regulatory navigation.
— Talents and Competencies
Regulatory clarity and structured execution
CMC regulatory strategy support and risk assessment
Health Authority interaction preparation
EU regulatory compliance and submissions
Cross-functional regulatory collaboration
CMC dossier architecture and review
Risk awareness and pragmatic problem solving
Calm delivery in complex environments
— CV / Professional Experience
Regulatory Affairs Professional
Nordic Regulatory Bridge | Ad hoc & interim support
I provide regulatory advisory support to organisations within clinical research and pharmaceutical environments, helping teams navigate regulatory requirements in a structured and pragmatic way. My work focuses on creating clarity, identifying gaps and translating regulatory expectations into concrete actions and realistic timelines.
I support organisations during periods of change, increased workload or transition, contributing with overview, consistency and a calm approach in complex settings. Assignments may include short-term or interim support, collaboration with internal teams and external partners, and advisory input to ensure progress while maintaining compliance and quality.
Regulatory Affairs Specialist / Principal Regulatory Specialist
Global pharmaceutical and life science companies
Over the past 15 years, I have held regulatory roles within established pharmaceutical and life science organisations, supporting regulatory submissions, compliance activities and cross-functional collaboration in EU-regulated environments. My experience includes working in matrix organisations, collaborating with internal teams and external partners, and contributing to regulatory clarity and progress across diverse portfolios.
— Education
SDU - Universitet of Southern Denmark
Master of Science in Engineering (Protein Chemistry) / 1999 - 2004
— Courses
Clinical trial statistics
Global company / 2025
Veeva Suite training
Global company / 2025