Regulatory Affairs Pharmacist: France
Contract type: Full time
Date listed: 02.11.2018
Job ref: 001-18
Alliance Pharma France is the French affiliate of Alliance Pharma Plc. Based in Paris, we are “exploitant" pharmaceutical site, as defined in the French Public Health Code. The activities, including wholesale and distribution of medicinal products, advertising, medical information, pharmacovigilance, batch follow-up, and if required, recall operations.
Alliance Pharma France is the marketing authorization holder of more than 10 medicinal products in France, mainly in Dermatology and has also in its portfolio different types of medical devices, cosmetics and one biocide. The company distributes its products through pre-wholesalers, wholesalers, retail pharmacies and hospitals.
We are recruiting in our Regulatory & Pharmaceutical Affairs department in Paris for a Regulatory Affairs Pharmacist to support the activities in France.
The Regulatory Affairs Pharmacist will have responsibility for performing the following duties:
Essential Job Functions
· Maintenance activities of MA, MA variation applications;
· Follow-up of submitted dossier and answer to the questions of the competent authorities;
· Interface with group entities and subcontractors on regulatory matters;
· Validation of promotional materials and training materials, application for a prior visa from ANSM;
· Control of packaging items in accordance with the MA and the regulations in force.
· Participate in the process of maintaining the certification of promotional information;
· Contribute to the maintenance and improvement of the quality system in place;
· Participate in the management of quality complaints and requests for medical information;
· Ensure traceability and archiving of regulatory documents.
Knowledge and skills
- +/- 1-year experience or significative internship in a French affiliate
- Good English level required
- Ability to complete work with minimal supervision and ability to work independently.
- Strong written and oral communication skills, ability to work closely and establish good professional and human relationships with people at all levels within Alliance structure and with service providers
- Good knowledge of French regulations
- Basic knowledge of quality assurance for exploitant
- Good organization skills and ability to prioritize
This position is to be filled in January 2019. The offer is for a permanent position.
Join the Alliance team
At Alliance Pharmaceuticals, we succeed together, and you will be part of a growing international organisation at an exciting point in its journey.
If you wish to apply for the position please send your CV and letter of motivation to email@example.com
It will be our pleasure to contact you for an interview at the earliest convenience should your profile correspond to our expectations.
No agency approaches please.