INTERNATIONAL REGULATORY AFFAIRS SPECIALIST M/FContract type: CDI
Country: Suisse (Genève)
Contact e-mail: email@example.com
Les Laboratoires Bailleul, an independent pharmaceutical group founded in 1949 and established in nearly 60 countries, is currently experiencing strong international development.
For over 65 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 Regulatory Affairs & Quality Director, you will be in charge of managing Regulatory Affairs Worldwide (except Europe) for Laboratoires Bailleul.
Your assignments will be centered on:
1. International Regulatory Affairs Management:
– Define the international registration strategy, outside Europe, in line with Bailleul Group’s strategy
– Manage the Regulatory Affairs officers of the subsidiaries and the local service providers, outside Europe, and follow up their activities
– Coordinate the Marketing Authorisations preparation and post-MA dossiers for submission, outside Europe, by the subsidiaries or local service providers
– Ensure harmonisation of the dossiers in collaboration with the Department of Regulatory Affairs for Europe, throughout Bailleul Group’s perimeter and within the areas concerned
2. Regulatory Files Preparation
– Write registration and post-registration records for the submission of the different products in the countries under its direct responsibility according to the defined regulatory strategy
– Plan submissions and submit files
– Establish, validate and distribute texts related to packaging materials and product information.
– Develop and monitor legal documents necessary for the marketing and export of products
– Answer the questions of the administrations and authorities and collect the necessary documentation
– Ensure the maintenance of the registration files, the follow-up and / or review of international post-registration files
– Manage and archive export registration files and regulatory information
3. Monitoring of pharmacovigilance and medical information
– Ensure relations between the local responsible for Pharmacovigilance and Bailleul
– Set up the SDEAs
– Participate and supervise the collection and monitoring of pharmacovigilance and medical information cases
– Validate reconciliations of PV and medical information cases by country
– Answer phone calls from patients about the different products
– Ensure initial and ongoing training of medical representatives
4. Regulatory Surveillance :
– Ensure regulatory, technological, scientific and competitive watch
– Advise and assist other department concerning regulatory process and requirements (development, production, quality, marketing, sales …).
– Prepare and deal with the legal documents required to market products.
Holding a pharmacist’s diploma and a Master 2 in Regulatory Affairs, you should have at least 6 years’ experience in International Regulatory Affairs.
You have excellent knowledge of the organization of International 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