Settore funzionaleAltra funzione aziendale
Organizational Unit: Global Regulatory Affairs
- 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.
University degree in a scientific discipline, such as Chemistry, Pharmacy.
- 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;
- 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
- Social intelligence and diplomacy
- 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