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REGULATORY AFFAIRS CONSULTANT HF

RÉFÉRENCE : VIE/105811/1122017


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détail de l'offre

SUISSE (Vernier)
du 01 mars 2018 au 01 septembre 2019 (pour 18 mois)
ETABLISSEMENT : SANOFI-AVENTIS GROUPE
REMUNERATION MENSUELLE : 2789€ (indemnité non contractuelle fixée par décret et arrêté, dont le montant peut varier notamment en
fonction de l’évolution du barème de référence, de la localisation de la mission et des cas d’abattements prévus par les textes)

Enterprise:
Sanofi is a global life sciences company committed to improving access to healthcare and supporting the people we serve throughout the continuum of care. From prevention to treatment, Sanofi transforms scientific innovation into healthcare solutions, in human vaccines, rare diseases, multiple sclerosis, oncology, immunology, infectious diseases, diabetes and cardiovascular solutions and consumer healthcare. More than 110,000 people at Sanofi are dedicated to make a difference in patients’ daily life, wherever they live and enable them to enjoy a healthier life.
Program SaVIE (VIE of Sanofi) is available to citizens of the European Economic Area (EU + Norway, Liechtenstein and Iceland) aged between 18 and 28.
PLEASE NOTE that since the VIE Program is primarily an international development program, candidates cannot apply to a VIE assignment in their own country of citizenship.
PLEASE NOTE that applications that are only submitted in French cannot be considered by our non-French speaking partners at Sanofi worldwide. Therefore, only applications that are submitted in English will be considered.

We are looking for a candidate for a VIE mission of:
Regulatory Affairs Consultant - VIE Contract (W/M)

JOB DESCRIPTION

Full integration into the Regulatory Affairs team of the Swiss affiliate.
The VIE will benefit from the experience of the team in place and will be trained in all the Swiss regulatory activities required for the position.
The VIE will participate in the daily activities, meetings and strategic thinking of the Regulatory Affairs Department and will be in charge of managing a product portfolio.
He will be in direct contact with the Swiss health authorities (Swissmedic).

Main challenges:

Participation in the main activities and responsibilities of the Regulatory Affairs Department:
- Preparation and submission of regulatory variations (Labeling, CMC) to Swissmedic
- Follow-up of submissions
- Management of Corporate requests concerning registered files
- Preparation and submission of special requests (co-marketings, Marketing Authorisation renewals, etc.)
- Participation in strategic registration discussions (within the department, with marketing, medical, logistics, etc.)
- Participation in specific projects (related to service, subsidiary or new products)
- Update or drafting of internal procedures
- Continuous updating of the Group and local databases
- Initiation and handling of submissions in eCTD (publishing)

CANDIDATE'S PROFILE

- Scientific university education (Master's degree required), preferably pharmacy studies, industry option
- Previous experience in Regulatory Affairs would be an asset
- At ease with computers in general and the use of common software (Word, Excel, PowerPoint)
- Good oral and written communication in French and English required, knowledge in German would be an asset

Job related skills required:

- Critical mind
- Conscientious, accurate, with a sense of organization and analysis
- Team spirit
- Flexibility

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Publiée le 01 décembre 2017
de Vernier
Activités en entreprises

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Nb de poste à pourvoir : 1

Expérience souhaitée : 12 mois

Niveau d'étude demandé : Bac + 5 et plus

Langue : Anglais , Français

Domaines de compétences : Marketing Pharmaceutique , Marketing , Management

Filière d'étude : MASTER , Maîtrise , MBA , MAGISTERE , MASTERE , Institut d'Administration des Entreprises , Institut d'Etudes Politique , Ecole de Gestion , Ecole Supérieure de Commerce

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