Regulatory Compliance Officer

Context

The candidate will join the Corporate Quality Department, Regulatory Compliance Office.

Job description

• Officially issue the registration documentation (eCTD - Module 3 "Quality") for the products under the responsibility of the Corporate Quality Department, after defining the regulatory needs, coordinating the various technical inputs and obtaining the substantial consent of the manager;
  
  
• Supporting Regulatory Affairs in the new registrations and renewals of Authorizations for Marketing and in the consequent definition of the activities related to the response of ministerial Deficiency Letters;
  
  
• Evaluate the dossiers, classify any non-conformities found and coordinate the activities of drafting the documentation inrequesting the execution of operational activities (e.g. stability studies, method development and validation, process validation, etc.).

Requirements

• Master’s degree in scientific disciplines, Pharmaceutical Chemistry and Technology, Pharmacy, Chemistry.
  
  
• The preference is for candidates who have gained professional experience, as employees of an industrial company, possibly in the regulatory or quality assurance departments.
  
  
• A good knowledge of both spoken and written English is essential. The position requires skills of problem solving, initiative and a strong predisposition to interpersonal relationships.