Regulatory Affairs Officer H/F

Job description

Informations générales

Référence

2017-3335

Date de parution

17/01/2018

Branche

Pharmaceutique

Société

PIERRE FABRE SANTE BENELUX S A

Description du poste

Intitulé du poste

Regulatory Affairs Officer H/F

Contrat

VIE

Durée du contrat

12

Taux d'activité

Temps plein

Mission

Within the Belgian subsidiary and reporting to the QRVI Manager and the Local Safety Officer, you contribute the daily missions in quality assurance, compliance and Ethics and Cosmetovigilance.

To the end, you will participe in :

- Participate to Regulatory duties respecting the commitments specified in the "Power of Attorney" and written signed by Corporate, particularly regarding local inspections;

- Submit registration/notification files for Pierre Fabre products to the appropriate local Authorities in accordance with the regulatory procedures and in accordance with the legislation in force;

- Ensure maintenance of marketing authorisations/notifications (e.g. renewals, variations, payment of fees as relevant, …);

- Where applicable, enter regulatory files and documents in the corporate documents database (as appropriate) and regulatory data in the Corporate regulatory database;

- Prepare and validate packaging information in accordance with the legislation in force;

- Validate promotional documents in accordance with the legislation in force;

- Inform immediately Corporate Regulatory Affairs of submission dates and approval dates and about any question on a product raised by a local Authority or any question from a consumer association/organisation aiming at publishing study results/analysis on a product;

- Organise the archiving and traceability of local files and documents;

- After prior validation by Corporate Regulatory Affairs, submit responses to request(s) for information from local Authorities.
- Send regularly an activity report to Corporate Regulatory Affairs. On a monthly basis for Cosmetics;

- Organise and prepare, in close contact with Corporate Regulatory Affairs, all necessary meeting with local authorities in order to solve any regulatory issue;

- Assist in any regulatory activity needed to ensure the reimbursement (if applicable), customs clearance and the commercialisation according to local legislation (e.g. registration of manufacturing sites,…);

- Regulatory Survey : provide accurate follow-up of the local legislation (organisation of survey; impact analysis on local portfolio; immediate reporting to the Corporate Regulatory Affairs)

- Participate in the preparation of all training/awareness of Pierre Fabre employees on existing local regulations and related future changes;

- Upon Corporate Regulatory Affairs request, participate in all meetings which aim at sharing international regulatory evolutions and organization/running methods within Pierre Fabre;

Profil

- Scientific Master Degree (Pharmacist ie) or equivalent (Scientific Degree/Life sciences)
- Minimum of 1 year experience in pharmaceutical and/or cosmetic industry in Quality Assurance Department
- Organizational and administrative capacity
- Rigorous
- Team Spirit, result oriented, auto-organization and process controlling.
- Analytical ability
- Fluent in French and English.
- Dutch is a plus

This is a VIE contract, please check the conditions of the French International Internship rogramme before applying: https://www.civiweb.com/EN/le-volontariat-international/VIE_CONDITIONS.aspx

Localisation du poste

Localisation du poste

Europe, Belgique

Lieu de travail

Bruxelles (Anderlecht)

Critères candidat

Niveau d'études minimum requis

Bac +4 / Bac +5

Diplôme

5-Mastère/Doctorat/Executive MBA

Niveau d'expérience minimum requis

1 an ou plus

Demandeur

Date de prise de fonction souhaitée

01/10/2017