Aurélie BUYENS
Aurélie BUYENSCEO | Pharm.D.

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Aurélie started her career in CENEXI Laboratoire in the Analytical Development Department. For about 5 years, she took over with a team the analytical transfers, the analytical developments and validations. The cleaning validation policy of the manufacturing site was also part of her activities.

She joined THERAMEX/TEVA Laboratoire in year 2007 in the Technical Writing Department, she rapidly held the strategic position of Responsible Pharmacist Deputy. Linked to her position, she was deeply involved in the Pharmaceutical Inspections and in the Release To Market Process for all the products of the firm. Few years later, she was promoted head of Technical Writing Department. So that, for the drug products portfolio of the company, Aurélie successfully monitored with a team the updates of Quality modules, the writing of variations. She thereby contributed to set up the regulatory strategy for European and International Markets, and coordinated the upgrading of all the documentation in the corporate database.

Moreover, while maintaining her responsibilities, she was trained as an external auditor and was involved in the implementation of the « charter of ethics » for the medical reps.
Year 2016 is the turning point : Aurélie co-founded the PharmaExperTEAM company.

Main Skills

CMC TECHNICAL WRITING
PHARMACEUTICAL RESPONSABILITY
QUALITY CONTROL/ANALYTICAL DEVELOPMENT
OTHER HEALTH PRODUCTS

Detailed View

– Regulatory Strategy for Europe and International countries, for a 14 drug products
– CMC-Compliance for MA files
– Writing of Variations, Modules 3 and 2.3
– Redaction Variations
– Management and Coordination of regulatory database system

– Registered as a Responsible Pharmacist Deputy, B section
– Involved in Pharmaceutical Inspections
– Pharmaceutical Release to Market Process

– Analytical Transfers
– Cleaning Validation
– Analytical Method Development
– Updated all files according to regulatory requirements (Cosmetic, Medical Device, Food Supplement)