Regulatory affairs assistant - Servier Laboratories : Job Details

ABOUT SERVIER

Founded to serve health, Servier is a global group governed by a Foundation that aspires to have a meaningful social impact, both for patients and for a sustainable world. With its unique governance model, it can fully serve its vocation with a long-term vision: being committed to therapeutic progress to serve patient needs.

The 21,900 employees of the Group are committed to this shared vocation, source of inspiration every day. As a world leader in cardiology, Servier's ambition is to become a focused and innovative player in oncology by targeting hard-to-treat cancers. Neuroscience and immuno-inflammatory diseases are the future growth drivers.

Headquartered in France, Servier relies on a strong geographical footprint in over 150 countries.

We are currently recruiting for the position of:

REGULATORY AFFAIRS ASSISTANT

Belgrade

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 all PV activities: Translating of adverse events, Fulfilling of ICSR forms, Preparation of PSURs for submission, Support training preparation, Support Post-Authorization Programs review.

* 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 & Professional Experience:

* University Degree in Pharmaceutical Science.

* 2 years in regulatory is an asset.

* PC Literacy: Microsoft Office Package active user

* Ability to work meticulously with attention to details and to ensure accuracy.

* Organizational skills, fast learning, team oriented.

* Fluency in English and Serbian knowledge (written and oral) is essential.

If you have the knowledge, skills, and a desire to work in a stimulating environment contributing to an innovative, research-based and people-oriented organization, recognized as GREAT PLACE TO WORK send us your CV. Please note that only shortlisted candidates will be contacted.