REGULATORY AFFAIRS OFFICER M/F IN LUXEMBURG en Laboratorios Bailleul

REGULATORY AFFAIRS OFFICER M/F IN LUXEMBURG
Laboratorios Bailleul
Laboratorios Bailleul, empresa especializada en dermatología, se fundó en 1949 y actualmente tiene presencia en más de 60 países.

Desde el inicio de nuestra actividad, hemos posicionado la calidad de vida del paciente como el centro de nuestro desarrollo, buscando siempre innovar a través de productos de calidad, con los que ofrecemos soluciones adaptadas a las necesidades de cada persona.

Para más informaciòn: http://www.bailleul.com
Barcelona, Madrid, Valencia, Sevilla, Málaga, Vizcaya, 30 Jun.
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Descripción
Company:

Les Laboratoires Bailleul, an independent pharmaceutical group founded in 1949 and established in nearly 80 countries, is currently experiencing strong international development.
For 70 years, we have always focused on improving the quality of life of patients, constantly seeking to innovate to bring solutions tailored to the needs of patients through quality products.
For more information: http://www.bailleul.com
Due to our international development, we are currently recruiting a Regulatory Affairs Officer (m/f) FOR LUXEMBURG OFFICE


Position:

Within the Laboratoires Bailleul Luxembourg and reporting directly to the Regulatory Affairs Director, you will join the team in charge of managing the Regulatory Affairs for the Laboratoires Bailleul.

Your missions will be to: Regulatory Affairs:
- Define the regulatory strategy for the registration activities and the post-authorization activities
- Prepare the marketing authorization and post-marketing authorization (renewal, variations) according to the defined regulatory strategy
- Insure the regulatory support to the other departments of the company
- Act as the key interlocutor for the health authorities
- Make the publishing of the files
- Coordinate and/or submit the files directly to the health authorities
- Follow-up the files
- Monitor the information in the data base
- Register the cosmetic products / food complements / and medical devices
- Write and maintain the procedures related to the Regulatory Affairs
- Insure the regulatory monitoring



Numero de vacantes: 1
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Requisitos
Profile:

Holding a pharmacy degree or equivalent, you have a first experience in Regulatory Affairs and/or Pharmacovigilance.
You have a good command of the organization of European health authorities and of the pharmaceutical, food complements, medical devices and cosmetics legislation.
Rigorous and autonomous, you have good analytical and listening skills and also show excellent writing skills.
Excellent commands of French and English are mandatory. A third language is an asset.

Estudios mínimos
Diplomado
Idiomas
Francés nivel Alto.
Inglés nivel Alto.
Experiencia mínima
1 año
Disponibilidad para viajar
El 100% del tiempo laboral



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