Global Quality Regulatory Affairs Manager Drug Product
Lisbonas soon as possibleFull-timePermanentYour TasksSubject 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 portfolioSupporting 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 complianceAnswering 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 customerAct as Regulatory Service Provider, within the scope of CDMO services (provide regulatory consulting)Representative of own responsibilities in customer audits and HA inspectionsSupport for QP / FvP by taking measures to ensure that production and QC testing comply with the submitted dossierGuidance in internal change control processes and Deviation Management with respect to Regulatory Affairs topicsYour ProfileMaster's degree in pharmaceutical sciences or similar qualificationAt least 5 years of professional experience in the pharmaceutical industry in the field of regulatory affairsIn-depth knowledge of FDA / EU GMP guidelines, especially in the area of Regulatory AffairsKnowledge of risk management and gap assessment principlesConfident use of electronic systems, ideally familiarity with an EQMS and EDMSExcellent interpersonal and communication skills; ability to build and maintain good working relationships and work productively with others as part of a teamHighly self-motivated with a "can do" mentality and a strong sense of personal responsibilityWe Offer
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