REGULATORY AFFAIRS OFFICER M/FContract type: CDI
Country: Luxembourg (LU)
Contact e-mail: firstname.lastname@example.org
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)
Within the Laboratoires Bailleul Luxembourg and reporting directly to the International Regulatory Affairs Director, you will join the team in charge of managing the Regulatory Affairs for the group Bailleul.
Your missions will be to:
- Regulatory Affairs:
- Define the regulatory strategy for all type of procedures in order to submit a new marketing authorization for drugs, a variation, a renewal, a maintenance request, answers to questions
- Insure the regulatory support to the other departments of the company
- Act as the key interlocutor for the health authorities
- Plan the submissions
- Organize meetings with authorities
- Prepare the generic documents according to the regulatory strategy, according to the right format and transmit them for local submission if necessary
- Prepare the application documents and write the administrative part
- Make the publishing of the files for their submissions
- Dispatch the ampliations received from local RA
- Submit the files directly through CESP or dispatch them to local RA for local submission
- Follow-up the submissions in each country and archive the files
- Monitor the data base
- Ensure the harmonization of marketing authorization files between the different countries
- Validate the Product Information Files and follow-up their updates according to the evolution of products DIP
- Transmit the regulatory texts for the realization of the ready for press
- Validate the master texts for the packaging articles and for the product information according to the European regulation in order for them to be reviewed by the local RA
- Register the cosmetics on the European portal (CPNP)
- Authorize the commercialization of products
- Write and maintain the Regulatory Affairs procedures
- Vigilances :
- Coordinate the preparation, elaboration and submit the specific pharmacovigilance documents according to the European requirements, ex: PSURs, RMP
- Follow-up the Referral, compile and submit the information or answers to questions asked
- Regulatory monitoring:
- Ensure the international regulatory monitoring and analyze their texts
Holding a pharmacy degree or equivalent, you have a first experience in Regulatory Affairs.
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.
Should you be interested, please send you application to email@example.com