CORPORATE REGULATORY AFFAIRS MANAGER
Gruppo Aboca
PG, IT
5 gg fa

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.
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