Regulatory affairs cmc & site regulatory specialist

Dompé farmaceutici is an international biopharmaceutical company involved in all activities of the pharmaceutical value chain, from research to development, production and marketing.

For our office in L'Aquila we are looking for a Regulatory Affairs CMC & Site Regulatory. The Regulatory Affairs CMC & Site Regulatory Specialist manages regulatory bodies, international parties in order to ensure constructive conversation and communication that allows the correct management of site activities and prepares CMC documentation for regulatory activities.

Responsibilities

• Interacts with international partners with the aim of guaranteeing communication of all site changes and regulatory compliance of the various products in the Dompé portfolio;


• Prepares the CMC documentation necessary for all regulatory activities (e.g. changes, renewals, request for new AICs);


• Performs Gap analysis to ensure constant regulatory compliance of all products in the Dompé portfolio;


• Evaluates the Change Controls in order to define the correct regulatory strategy by modulating the activations of the various changes based on regulatory requirements;


• Guarantees regulatory support to all corporate functions;


• Is constantly updated with regard to regulatory legislation and guidelines and verifies/applies the correct reference legislation in the process managed;


• Ensures the archiving of all documents, according to the defined flow;


• Ensures compliance with the law and regulations in compliance with the model of the control pursuant to and for the effects of D. Lgs. 231/01 and codes of conduct within its area of competence;


• Ensures compliance with legal requirements and procedures on occupational safety and hygiene as well as environmental protection within its area of responsibility.

Qualifications

• Bachelor’s/Master’s Degree in Chemistry, CTF, Biological Sciences, Pharmacy or related discipline;


• Experience in a similar role, preferably in the Pharmaceutical/Life-science sector.

Required Skills

• Languages: Italian & English (fluent);


• Knowledge of the main productivity and collaboration tools (Google Workspace, MS Office);


• Knowledge of SAP operating systems and corporate ICT platforms;


• Knowledge of the main medical-scientific databases;


• Knowledge of the main databases for the management of scientific documentation;


• Knowledge of the RIM system;


• Knowledge of the Change Control System;


• Knowledge of regulation concerning the preparation of CTD documentation;


• Knowledge of eCTD Manager;


• Knowledge of the FirstPoint platform (R&D);


• Knowledge of Farmindustria deontological code;


• Knowledge of pharmaceutical regulation;


• Knowledge of the Pharmaceutical sector.