Regulatory Affairs Specialist

Azienda

Our client, a leading pharmaceutical company, is looking for a Regulatory Affairs Specialist.

Descrizione Lavoro

Main Responsibilities of the role:

• 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.
• eCTD management
• Support the development of the strongest claims/advertising and promotion possible within the regulations, obtaining the required authorization;

Competenze ed esperienza

• Relevant previous experience of at least 5 years of experience in Regulatory Affairs preferably in Corporate roles
• Good knowledge of pharmaceutical, laws and regulation (Italy, EU countries, extra EU) and fluent management of the life cycle management
• Scientific Degree (Pharmacy, Pharmaceutical chemistry, Chemistry or related disciplines) and Master in Regulatory Affairs is preferred
• Good communications skills
• Curiosity, precision and organization
• Ability to work autonomously or in a cross-functional Team.
• Very Good English proficiency

Completa l'offerta

Great opportunity