Nathalie AZÉMARD
Nathalie AZÉMARDGeneral Manager | Pharm.D.

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Nathalie started her working life in Hoechst Marion Roussel Laboratoire where she gained experience in the field of Medical Devices.

She integrated THERAMEX/TEVA Laboratoire in 1999, where she became Export Registration Manager. She carried out registration and post approval follow-up for the entire range of products for all countries covered (Asia, Latine America, Central America, Africa, Middle-East, Easthern Europe, Switzerland).

Nathalie was appointed Registration Manager for Europe in 2002, taking over the regulatory management of a range of products. She achieved the registration of a medicinal product via MRP after update of the entire file according to current requirements. She also acquired significant experience in activities linked to « Exploitant » Responsibility, taking in charge advertising and labelling review.

In 2005, she was promoted Senior Regulatory Manager for a range of products. She was actively involved in registration of an innovative product via CP, as project leader and EMA contact person. Furthermore, she was responsible for DMOS implementation through the firm and subsequent training of medical representatives.

She decided to make her career move in 2013 and joined the CMC unit, where she took over the update of quality modules including regulatory strategy and CMC compliance.

In 2016, Nathalie moved to consultancy and built PharmaExperTEAM.

Main skills

REGISTRATION IN EUROPE
WORLDWIDE REGISTRATION
CMC TECHNICAL WRITING
EXPLOITANT ACTIVITY

Detailed view

– Involved in all registration procedures (CP, DCP, MRP, National)
– Provided Regulatory Strategy
– Successfully registered an innovative product via CP as project leader and EMA contact person
– Made the registration of a drug product via MRP happen, further to the update of the dossier according to current regulatory requirements

– All countries (Africa, Asia, Eastern Europe, Latin America, Central America, Switzerland, Middle East)
– Provided Regulatory Strategy
– Registered a range a products according to local requirements

– Regulatory Strategy for Europe and International countries
– Writing of modules 3 et 2.3
– Writing of variations
– Managed Corporate Regulatory Databases

– Advertising and labelling review in compliance with pharmaceutical regulations and ethical principles
– DMOS
– Pharmacovigilance