Regulatory Specialist and Senior Specialist

21 ago - Italia
Michael Page International Italia

Azienda
Our client, a leading pharmaceutical company, is looking for a Regulatory Affairs Specialist.
Provide Corporate Regulatory input into the development of new products and due diligence initiatives.
Obtain and maintain registration of company's new and existing products worldwide.
Support local marketing companies (affiliates and distributors) to ensure fast product registration and good product life cycle management.
Manage preparation of new regulatory documents, dossiers, and applications to enable products to be launched and maintained in market.
Support key processes related to CMC, quality, labelling, artworks, and local regulations.
Competenze ed esperienza
Relevant previous experience of at least 5 years in Regulatory Affairs, preferably in Corporate roles.
Good knowledge of pharmaceutical laws and regulations (Italy, EU countries, extra EU) and fluent management of the life cycle management.
Scientific Degree (Pharmacy, Pharmaceutical chemistry, Chemistry, or related disciplines) and a Master in Regulatory Affairs is preferred.
Good communication skills.
Very good English proficiency.

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