We offer a position as Regulatory Affairs Officer (m / f) with previous experience in the pharmaceutical
sector and excellent command of the English language, who is able to :
Support the Head of the Regulatory Affairs Department in the development of registration dossier
concerning different product categories (substance-based medical devices, medicinal products, foods for
special medical purposes, fodd supplements);
Manage registration procedures with regulatory bodies;
Support the internationalization process of the Aboca Group, through the systematic study of non-European
laws and "gap analysis";
Maintain ongoing relations with institutional bodies and the main sector associations.
We are looking for a candidate (m / f) who :
has a university degree in scientific subjects and a solid scientific background;
has a proven professional experience in regulatory affairs of at least 5 / 8 years in structured companies;
is experienced in drafting technical files and in maintaining ongoing institutional relations for the purpose
of carrying out registration processes (medicinal products, medical devices, food supplements).
A specific know how in the certification of substance-made medical devices would be an advantage.
is able to maintain ongoing relations with institutional bodies and the main sector associations;
speaks fluent English;
works independently, is flexible, precise and has pronounced analytical capabilities;
is willing to travel worldwide;
is willing to reside in the Tiber Valley (PG-AR) (Italy);
is car owner.