Regulatory affairs cmc & site regulatory specialist

Dompé; L'Aquila; In loco; EUR 40.000 - 60.000; Tempo pieno

Descrizione del lavoro

A leading biopharmaceutical company in L'Aquila is seeking a Regulatory Affairs CMC & Site Regulatory Specialist. In this role, you will manage regulatory bodies, prepare CMC documentation, and ensure compliance with all regulations affecting site activities. The ideal candidate will hold a Bachelor's or Master's degree in relevant fields and have experience in a similar role within the Pharmaceutical sector. Fluency in Italian and English is required, along with familiarity with various regulatory systems and documentation processes.

Competenze

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

Mansioni

• Interact with international partners to guarantee regulatory compliance.
• Prepare CMC documentation for all regulatory activities.
• Perform Gap analysis for constant product compliance.
• Evaluate Change Controls for appropriate regulatory strategy.
• Provide regulatory support to all corporate functions.
• Stay updated with regulatory legislation and guidelines.
• Archive documents according to defined flow.
• Ensure legal compliance regarding safety and environmental protection.

Conoscenze

Fluent Italian

Fluent English

Knowledge of productivity and collaboration tools

Knowledge of SAP

Knowledge of medical-scientific databases

Knowledge of scientific documentation management

Knowledge of RIM system

Knowledge of Change Control System

Knowledge of CTD documentation preparation

Knowledge of eCTD Manager

Knowledge of FirstPoint platform

Knowledge of Farmindustria deontological code

Knowledge of pharmaceutical regulation

Knowledge of Pharmaceutical sector

Formazione

Bachelor’s/Master’s Degree in Chemistry, CTF, Biological Sciences, Pharmacy

Descrizione del lavoro

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.