Introduzione

I vostri compiti

• Subject Matter Expert in Regulatory Affairs for the Corden Pharma Drug Product Sites (Lisbon, Fribourg, Plankstadt, Ettingen)
• Responsibility for customer inquiries regarding regulatory matters for new projects and in the life cycle of the existing product portfolio
• Supporting regulatory applications/variations related to the product and/or manufacturing site by preparing submission documents in a timely manner and providing advice on regulatory requirements and GMP compliance 
• Answering questions from health authorities regarding the manufacturing site and/or the regulatory quality dossier section of the product (Module 3: Manufacturing/ Composition/ Specifications/ Analytical Methods/ Packaging Specifications/ Stability)
• Single point of contact to ensure Establishment Registration and current registration with health authorities where Corden Pharma acts independently, e.g. local European agencies, FDA, PMDA or in cooperation with the customer, e.g. ANVISA, EAEU and all other applicable international markets.
• Responsibility to maintain the EMA SPOR database and archive of regulatory dossiers approved in each country for the products manufactured in accordance with the established Quality Agreement with the customer
• Act as Regulatory Service Provider, within the scope of CDMO services (provide regulatory consulting)
• Representative of own responsibilities in customer audits and HA inspections 
• Support for QP / FvP by taking measures to ensure that production and QC testing comply with the submitted dossier
• Guidance in internal change control processes and Deviation Management with respect to Regulatory Affairs topics

Il tuo profilo

• Master's degree in pharmaceutical sciences or similar qualification
• At least 5 years of professional experience in the pharmaceutical industry in the field of regulatory affairs
• In-depth knowledge of FDA / EU GMP guidelines, especially in the area of Regulatory Affairs
• Knowledge of risk management and gap assessment principles
• Fluent in english 
• Confident use of electronic systems, ideally familiarity with an EQMS and EDMS 
• Excellent interpersonal and communication skills; ability to build and maintain good working relationships and work productively with others as part of a team
• Highly self-motivated with a “can do” mentality and a strong sense of personal responsibility