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Regulatory Affairs Manager

il y a 2 semaines

Luxembourg MD Skin Solutions Temps plein

**Objectives**:

- Facilitate the company's expansion in new markets by handling the registration of its products in countries outside the EU, while taking charge of product notification within the EU.
- Ensure ongoing compliance of the company's registered products with applicable regulatory requirement.
- Provide cutting-edge expertise on norms and legislation as needed across countries of operations

**Responsilities**:
Locate, collect, review, complie and deliver the list of required documents to the regulator every (1) product registration, (2) subsequent renewal, and (3) regulatory update.

Assist the RA Manager in adapting existing documents and/or producing new ones, while coordinating internally the actions engendered by special labelling requirements.

Develop GFH's regulatory monitoring capability on its registered products, enhancing the timely recognition of country-specific triggers and sllowing for and adequate response.

take an active role in the communication with RA service providers, and coordinating their actions.

Deal with ad-hoc inspections and requests

Type d'emploi : Temps plein

Langue:

- anglais (Optionnel)
- français (Optionnel)

Disponibilité:

- Travail en journée (Optionnel)