Global CMC & Site Regulatory Strategist

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

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.