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Informazioni offerta

Sede

Parma

Settore funzionale

Altra funzione aziendale

Descrizione

Organizational Unit: Global Regulatory Affairs

Responsibilities:  

  • All regulatory activities for dossier preparation, consolidation, and customization by countries to ensure timely submissions, responses to authorities, granting of MA and maintenance of products in the specified markets. 
  • Preparation of regulatory dossiers for New Marketing Authorization, Applications, Renewals, Company Registrations and support to Life-Cycle Management activities. 

Education: 
University degree in a scientific discipline, such as Chemistry, Pharmacy.

Experience:

  • 2 years of experience in Regulatory Affairs within the Pharma industry of which, at least 1 year in International Regulatory Affairs; 
  • experience within RA for Extra EU Countries will be a plus; 

Technical skills: 

  • Good knowledge of the International regulatory environment 
  • Good knowledge of main CMC, pre-clinical and clinical concepts 
  • Good knowledge and understanding of drug development (general concepts) 
  • Good knowledge of the registration dossier (format and content) and the most significant regulatory guidelines 

Soft skills: 

  • Open-mindedness
  • Social intelligence and diplomacy 
  • Flexibility 
  • Intercultural skills 
  • Problem-solving attitude 
  • Perseverance and ability to planning and following projects 
  • Teamwork attitude 

Languages: fluency in English is a must

Type of contract: Permanent

Location: Parma, Italy 


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