Regulatory Manager m/f
For over 60 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
Reporting directly to the Head and Deputy Head of Qualified Personnel at Laboratoires Bailleul Luxembourg, you will be in charge of managing Regulatory Affairs Europe for Laboratoires Bailleul.
You will be supported by a team of 3 people (senior and junior regulatory affairs managers, etc.).
Your assignments will be centred on:
- Coordinating the Marketing Authorization policy:
- Coordinating the compiling of marketing authorization and post-marketing authorization files for submission in European countries.
- Dealing with questions from authorities and collecting the additional information required
- Dealing with maintaining marketing authorization / renewal, variation type I and II, transfer of marketing authorization holder and operator
- Being in charge of drafting the administrative and/or pharmaceutical part of marketing authorization files
- Checking and validating the compliance of packaging materials for medication, food supplements and cosmetic products and submission to health authorities
- Regulatory watch:
- Ensuring regulatory, technological, scientific and competitive watch
- Making declarations of interest
- Preparing and following up the legal documents required to market products
- Acting as the key contact person for the departments concerned (development, quality production, marketing, sales, etc.) on regulatory aspects
- Monitoring of pharmacovigilance and medical information
- Providing the interface between QPPV and EU-QPPV
- Taking part in and overseeing the gathering of pharmacovigilance cases and medical information, and ensuring the transfer to the pharmacovigilance provider
- Validating the reconciliation of pharmacovigilance cases and medical information by country
- Answering phone calls from patients who have questions about our various products
- Ensuring the initial and ongoing training of promotional network staff
- Being in charge of preparing and submitting PSURs in accordance with European requirement
- Holding a pharmacist's diploma and/or a Master 2 in Regulatory Affairs, you should have at least 8 to 10 years experience in Regulatory Affairs.
You have excellent knowledge of the organization of European health authorities and pharmaceutical / food supplements / dermatology legislation.
You are acknowledged by your teams as a thorough and self-reliant manager.
Possessing good inter-personal skills, you know how to dialogue and transfer knowledge.
An excellent command of French and English is required. A third language is an advantage.
If you are interested by this position, please send us your candidature to: firstname.lastname@example.org
If you are interested by this position, please send us your candidature to:
Human Resources Manager
While applying for the job please refer to jobvector and use the following reference number: LBLUX/RM/JbV
Human Resources Manager
About Laboratoires Bailleul
Les Laboratoires Bailleul, an independent pharmaceutical group founded in 1949 and established in nearly 40 countries, is currently experiencing strong international development. For over 60 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...More about Laboratoires Bailleul