CMC MANAGER M/FContract type: CDI
Country: Genève (Suisse)
Contact e-mail: email@example.com
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
Within the Laboratoires Bailleul International and reporting directly to Quality & CMC Director, you will be in charge of the technical-regulatory affairs:
- Compliance of the documentation
- Audit regulatory files in accordance to the local regulatory requirements of the different countries
- Participate to the definition of the adequate strategy in order to submit the files at the earliest convenience
- Prepare the necessary documentation to the editing of the module 3
- Write and validate the module 3 and the module 2.3
- Supervise the editing and the maintenance of food complements technical files
- Supervise the editing and the maintenance of product information files of cosmetic products
- Responsible of the files’ follow-up
- Follow-up the necessary actions to respond to health authorities
- Prepare the responses to the questions of health authorities as part of the submissions
- Edit and validate the modules depending on the responses to the health authorities’ questions
- Edit and validate the modules depending on the pharmaceutical variations to submit to the health authorities
- Edit and validate the modules depending on the changes initiated by the manufacturing sites or the raw material manufacturers
- Responsible of the regulatory monitoring
- Insure the regulatory, technologic and scientific monitoring, related to the pharmaceutical files and medical devices technical files
- Elaborate and follow-up the strategies related to these regulatory evolutions
- Advise and assist the concerned services (development, production, quality, marketing, sales…) on regulatory aspects.
- Responsible of transfers/ product developments follow-up
- Participate to industrial transfers of pharmaceutical products in third countries or between manufacturing sites: follow-up of the project, review and validate the protocols and manufacturing reports, analytic reports, be a support to the manufacturer while ensuring the regulatory conformity of the documents in accordance to the applicable standards
- Participate to the development of new products (pharmaceuticals, cosmetics and food complements) or active principal on the production or analytic part and redaction of the regulatory files
Holding a pharmacy degree and a Master 2 in Regulatory Affairs or analytical chemistry, you have an experience of at least 5 years in Regulatory Affairs and in particular in the writing of module 3 CTD format pharmaceutical files and medical devices technical files.
You have a good knowledge of the pharmaceutical legislation and medical devices.
Pedagogue and having good personal relationship skills, you have a good analytical skills and are recognized for your writing qualities.
Excellent command of English is mandatory.
Should you be interested, please send you application to firstname.lastname@example.org