Especialista en Asuntos Regulatorios

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7a6r5i

With its beginnings in a family run pharmacy in Correggio, Italy in the 1920s, Recordati is now a global pharmaceutical company, listed on the Italian stock exchange, with over 4,500 employees and turnover of over Euro 2bn.
We develop and commercialise medicines to serve people living with common diseases, as well as those living with some of the rarest, in around 150 countries.
We’ve always believed that health, and the opportunity to live life to the fullest, is a right, not a privilege. This drive will never stop. Together, we will always be reimagining tomorrow – with new ideas, new technologies and new innovations to fight diseases.
We are looking for a Regulatory Affairs CMC Specialist who has consolidated experience on Chemistry, Manufacturing and Control (CMC) aspects in order to manage the preparation of dossiers for submission to regulatory authorities worldwide.
Writing and managing technical sections of Module 3 in collaboration with relevant departments/functions




Competence on how to translate technical reports into regulatory documents suitable for submission to the Regulatory Authorities
Assessment of Modules 3 of existing products in order to predict the potential future regulatory impact associated with those products and related variations
Conduct regulatory assessments for CMC change controls
The figure sought is a Specialist in the Regulatory CMC sector with an extremely technical cut who has previous business experience (eg manufacturing Compliance, Regulatory CMC).
~3+ years working experience in CMC regulatory affairs
~ The resource must have adequate skills to understand and deal with the "intelligent and targeted" writing of a section of Module 3 in order to place in it the correct information expected by Regulatory Authorities. The resource must know the guidelines governing the CMC sector, such as GMP, ICH Q, EMA Quality guidelines, WHO guidelines and must be able to interpret these guidelines according to the product to be managed.
~ Anal

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7a6r5i