Regulatory Affairs Assistant
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ABOUT SERVIER
We are an international and independent pharmaceutical company governed by a non-profit foundation, with headquarters in Suresnes, France. Operating in 149 countries, we have 22,000 collaborators employed worldwide and a turnover of 4.176 billion euros in 2018. Entirely independent, we are able to reinvest 25% of our total revenue (excluding generics) into Research and Development, and all profits are used for further development.
Corporate growth at Servier is driven by our continuous pursuit of innovation in five areas of excellence: cardiovascular and immune-inflammatory diseases, neuropsychiatric disorders, cancer and diabetes; we also manufacture high-quality generic drugs. For more information, visit www.servier.com
We are currently recruiting for the TEMPORARY position of:
Regulatory Affairs Assistant
WHAT YOU WOULD BE RESPONSIBLE FOR:
Assisting in preparation of dossiers for registration, variation or renewal application of medicinal products for the territory of Serbia, Montenegro, Albania.
Preparation of local language documents (SmPC, PIL, labeling) for the registration submissions.
Maintenance of appropriate archive (electronic documentation and/or paper) to ensure traceability and compliance.
Maintenance of local tracking and company regulatory affairs tracking system, databases of registered medicinal products, Product Information and SOPs in Serbia, Montenegro and Albania.
Support in preparation of promo material for Serbia, Montenegro and Albania.
Support in regulatory compliance of the local Servier website.
Administrative support of Regulatory Affairs department.
KNOWLEDGE, SKILLS, and PROFESSIONAL EXPERIENCE WE ARE LOOKING FOR:
Fluency in English and Serbian knowledge (written and oral) is essential.
Whatever your area of expertise, your work within the Servier Group helps advance therapeutic progress for the benefit of patients. You will be part of teams recognized for their scientific excellence and reach your full potential in a professional environment that encourages you to develop yourself. Tailor-made onboarding journeys, mobility opportunities, quality trainings, responsible management, team spirit... All this and more in a workplace focused on your well-being.
At Servier, we are committed to therapeutic progress to serve patient needs. We put the diversity of our employees as a source of richness for the fulfillment of this vocation.