Export Regulatory Affairs Manager (M/F) - CDI - PURESSENTIEL

Puressentiel is an independent family-owned company and the market leader in aromatherapy in pharmacies in France and Europe. The brand, which celebrated its 15th anniversary, has developed a unique know-how: the creation of ready-to-use formulas combining synergies of essential oils and the purest active ingredients, designed to treat the everyday ailments of the whole family: indoor air purification, joint or muscle comfort, sleep, stress, slimming…

In order to accompany us in our development, we are looking for:

A Regulatory Affairs Manager for Export (M/F), on a permanent contract

MISSION

Within the Regulatory Department of the Regulatory, Quality and Product Safety Division, whose mission is to mission is to market safe and compliant products worldwide, in close collaboration with the with the Development, Marketing and Export departments, the Export Regulatory Affairs Manager is the is the reference in the validation of the conformity of the finished product at the level of export countries (Asia, South America, Middle East, European Union).

As such, perfectly bilingual, you will be responsible for :
- The constitution, the validation, the update of the technical files of the Products and their The creation, validation and updating of technical files for products and their communication supports in accordance with local regulations,
- Managing relations with local authorities, notified bodies and regulatory contacts,
- Issuing and transmitting the technical documents necessary for the regulations at the international level international level,
- Update databases and ensure regulatory monitoring,
- As part of your duties, you will also participate in all regulatory missions of the department of the department’s regulatory missions on the company’s product portfolio and you will be responsible for of the quality management system with the employees

PROFILE REQUIRED

BAC + 5, engineering school or Doctor of Pharmacy with a MASTER in Regulatory Affairs.
You have professional experience (2 to 5 years) of European and international regulatory requirements for health products (devices, drugs, etc.). (medical devices, cosmetics, food supplements, biocides, etc.) including You know the sources of information (European Directive, draft regulation, standards, professional associations standards, professional associations…) and master the scientific data related to the products (mechanism of action related to the products (mechanism of action…). You like to work in an international context.

You are a person of dialogue, you like to work in a team, you know how to prioritize and plan actions.
You are autonomous, rigorous, curious, friendly, adaptable with a spirit of analysis and and synthesis.

PRACTICAL INFORMATION

Sector : Regulatory, Safety and Product Quality
Starting date : As soon as possible
Location : Paris
Type of contract : CDI

Please send your CV and cover letter to recrutement@puressentiel.com