International Clinical Regulatory (m/f)

Our client is Chiesi Farmaceutici.
Your task is to handle all the clinically-related regulatory activities concerning:

- New registrations (preparation of the clinical parts of the dossier, wherever necessary to adapt the Global or Corporate ones to country-specific requirements; preparation of clinical response documents to the objections raised by Competent Authorities) ;
- Variations to existing authorisations, wherever the clinical parts of the dossier (including SmPC and leaflet) are involved ;
- Renewals of existing authorisations (clinical parts, SmPC, leaflet);
- Pricing/reimbursement (preparation of pharmaco-economic evaluations, in cooperation also with the Area Manager concerned);
- Clinical trials, from phase I to IV, that may be run for regulatory purposes (such as, but not limited to, preparation of Clinical Trial Applications), in cooperation with Corpor ate Clinical Development;
- Regulatory Intelligence (gathering, analyzing and circulating the most important clinical information on competitors and any other interesting products);
- Preparation and update of SmPC and leaflets, in cooperation with the Regulatory Manager of the country concerned;
- Definition of regulatory strategies for the global clinical development of Corporate products and submission of applications therein;
- Preparation of Scientific Advice, Protocol Assistance and any other meetings with the Competent Authorities.

Requirements:

University degree in Human Medicine or, if not feasible, in Chemistry and Pharmaceutical Technology or Biological Sciences
At least 3 to 4 years of experience within Regulatory Affairs of which at least three in the international context
- Very good knowledge of the ICH clinical guidelines, particularly (but not limited to) for respiratory products
- Good knowledge of the main clinical concepts applied to Regulatory Affairs
- Good knowledge and understanding of drug development (general concepts), both global and regional
- Very good knowledge of the registration dossier (format and content)
Ability to deal with Clinical Officers of international Regulatory Agencies

Contact:

AIMS International Italy
Ms. Alessandra Trivellato
Via Salvini, 3
20122 Milano
Tel.: +39 (0) 76394366
alessandra.trivellato@aimsitalia.com