Regulatory Affairs Specialist

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7hvuat

Azienda
Our client, a leading pharmaceutical company, is looking for a Regulatory Affairs Specialist.
Offerta
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
Qualifications & Skills
- 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.
- Curiosity, precision, and organization.
- Ability to work autonomously or in a cross-functional team.
- Very good English proficiency.

Completa l'offerta
Great opportunity.
J-18808-Ljbffr

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7hvuat