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Regulatory Affairs Manager m/f

Workscope: Regulatory Affairs

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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.
As part of our international expansion, we are recruiting a Senior Regulatory Affairs Manager (M/F) and a Junior Regulatory Affairs Manager (M/F).
For more information: http://www.bailleul.com
Reporting directly to the Regulatory Manager at Laboratoires Bailleul Luxembourg, you will be in charge of managing Regulatory Affairs Europe for Laboratoires Bailleul.
You will be responsible for:
  • Drawing up the Marketing Authorization policy:
    • Preparing the marketing authorization and post-marketing authorization files for submission in European countries according to defined regulatory strategy,
    • Providing answers to questions from authorities and gathering any required additional information
    • Taking part in maintaining marketing authorization / renewal, variation type I and II, transfer of marketing authorization holder and operator
    • Drafting the administrative and/or pharmaceutical part of the marketing authorization files
    • Checking and validating the compliance of packaging materials for medication, food supplements and cosmetic products and submission to health authorities

  • Participating in the regulatory watch:
    • Analysing texts arising from regulatory, technological, scientific and competitive watch
    • Making declarations of interest
    • Preparing and ensuring the follow-up of legal documents required to market products
    • Playing an advisory role and assisting with regulatory aspects in the relevant departments (development, quality production, marketing, sales, etc.)

  • Monitoring of pharmacovigilance and medical information
    • Act as the interface between QPPV and EU-QPPV
    • Taking part in gathering pharmacovigilance cases and medical information, and ensuring the transfer to the pharmacovigilance provider
    • Validate the reconciliations of pharmacovigilance cases and medical information by country
    • Answering phone calls from patients who have questions about our various products
    • Ensuring the initial and continuing training of promotional network staff
    • Drafting the PSURs according to European requirements for review by the Regulatory Manager
 
  • Holding a pharmacist's diploma or a Master 2 in Regulatory Affairs, you should have at least 5 years experience in Regulatory Affairs for the Senior position and 3 years (year end internship included) for the Junior position.
    You have a solid understanding of the organization of European health authorities and pharmaceutical / food supplements / dermatology legislation.
    You should be thorough and independent, have good analytical and listening skills as well as excellent writing skills.
    An excellent command of French and English is required. A third language is an advantage.
If you are interested in this position, please send your CV to: bailleul-809699@cvmail.com

Contact detail


How to apply:
If you are interested in this position, please send your CV to:
Laboratoires Bailleul
Olivier MAUNOURY
bailleul-809699@cvmail.com
Send application to
If you are interested in this position, please send your CV to:
Laboratoires Bailleul
Olivier MAUNOURY
bailleul-809699@cvmail.com

Job profile


Working hours
Full-Time
Contract duration
Permanent
Type of job
Specialist
Work experience
job experience is not required
Region
Germany
Working place
L-2124 Luxembourg Kirchberg
Area of expertise
Pharmaceutics
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