M.Sc. Eng., Regulatory Affairs Manager
Mette Linnea Jensen holds a Master of Science in Engineering with specialisation in Chemical Engineering and has joined Billev Pharma in February 2026 as a Regulatory Affairs Manager.
Mette has more than 12 years’ experience within Regulatory Affairs CMC from the pharmaceutical industry, primarily from Global Danish Pharmaceutical Companies.
Mette’s experience covers:
- Regulatory CMC lifecycle management
- Preparation and maintenance of CMC documentation (CTD Modules 1–3)
- Variations and post-approval changes
- Technology transfers and site transfers
- Regulatory change control and impact assessments
- Cross-regional submissions
- Close collaboration with QA, technical, manufacturing and supply chain functions
Services
Registration
We are well-equipped to provide regulatory advice, discuss strategy and/or compile the registration dossier.
Pharmacovigilance
We have a team of highly qualified pharmacovigilance employees with expertise in all aspects of pharmacovigilance.
Translations
We offer high quality medical & pharmaceutical translations into and from several European languages.
Electronic submission
We are equipped to assist with any type of electronic submission and maintenance of your electronic file.
Special medicines areas
Herbal medicinal products, strong vitamin and mineral products, medicinal gasses, euphoriant substances, etc.
GDP & GMP Services
We offer full time and part time responsible person (RP) function and qualified person (QP) function.
Latest News
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