6 AXEPTA SA Jobs

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Global Regulatory Affairs Manager OTC
AXEPTA SA
Vaud
vor 4 Tagen
Ingénieur Assurance Qualité
AXEPTA SA
Fribourg
Heute
Manager Assurance Qualité
AXEPTA SA
Fribourg
Heute

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Chef-fe de dépôt

AXEPTA SA

Genève

Responsable étude de prix
AXEPTA SA
Genève
vor 4 Tagen
Ingénieur de projets EIA
AXEPTA SA
Valais
vor 4 Tagen

von 1 Seiten

Global Regulatory Affairs Manager OTC

AXEPTA SA

Vaud

vor 4 Tagen

Online bewerben

My client is an innovating, dynamic and growing international pharmaceutical and healthcare company currently expanding their Global Regulatory Affairs team in Switzerland, Vaud Canton.

Due to this growth my client is looking for a Global Regulatory Affairs Manager with experience working on OTC/Drugs combination Products at global level.

Global Regulatory Affairs Manager OTC

My client is an innovating, dynamic and growing international pharmaceutical and healthcare company currently expanding their Global Regulatory Affairs team in Switzerland, Vaud Canton.

Due to this growth my client is looking for a Global Regulatory Affairs Manager with experience working on OTC/Drugs combination Products at global level.

Key deliveries & accountabilities:

Contributes to the development, preparation of dossiers and global coordination of OTC drugs for regulatory aspects for worldwide registration. The role also includes knowledge on Medical Devices.
Setting up the regulatory strategy for projects under development
Coordinates the preparation and participates to meetings with Health Authorities/Notified Bodies if necessary
Communication of project relevant RA information to Project Team and Department Heads
Represents RA in global & cross functional meetings
Provides regulatory support to ensure the content of dossier/technical files is compliant with relevant regulations and is sufficient for submission
Updates Product Information periodically or upon specific request
Ensures regulatory support for new product launch
Maintains and tracks RA activities databases
Supports the development of labelling and artworks

Work Experience:

Minimum 5 years of prior experience in global Regulatory Affairs in the Consumer Care environment (OTC drugs and Medical Devices).
PhD (in Sciences, Medicine or Pharmacy), Master or any equivalent advanced scientific degree in a related technical field.
Strong knowledge of the OTC drugs and Medical Devices industry, including solid knowledge of all associated global RA regulations.
Experience in classification change / OTC switch is a plus
Experience in combination product is a plus

6 AXEPTA SA Jobs

Diese Suche abonnieren

Global Regulatory Affairs Manager OTC

Ingénieur Assurance Qualité

Manager Assurance Qualité

Diese Suche abonnieren

Chef-fe de dépôt

Responsable étude de prix

Ingénieur de projets EIA

Vaud

Global Regulatory Affairs Manager OTC

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