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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