Michael Page
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 be st 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 variation such as 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.
Qualifications & Skills
- 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 of Human medicinal products
- 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
Our client, a leading pharmaceutical company, is looking for a Regulatory Affairs Specialist.
Great opportunity
Settore: Altro
Ruolo: Middle e Top Management