Regulatory Affairs Specialist

JR Italy; Roma; In loco; EUR 40.000 - 60.000; Tempo pieno

Descrizione del lavoro

Un'importante azienda nel settore farmaceutico cerca un Regulatory Affairs Specialist per supportare la conformità normativa e gestire la documentazione tecnica. Il candidato ideale avrà una laurea in CTF o affini, esperienza di almeno 5 anni, e conoscenza delle GMP. L'azienda promuove un ambiente di lavoro inclusivo e innovativo, rispettando la diversità e le esperienze di tutti.

Competenze

• 5 anni di esperienza in ruoli simili in organizzazioni complesse.
• Conoscenza della normativa GMP.
• Conoscenza dell'inglese a livello lavorativo.

Mansioni

• Supportare il monitoraggio della conformità normativa del sito.
• Gestire la documentazione tecnica relativa agli agenti avventizi.
• Supportare i clienti nella fase di registrazione e post-registrazione.

Conoscenze

Conoscenza delle GMP

Competenze in documentazione tecnica

Lavoro in team

Gestione dei documenti

Formazione

Laurea Magistrale in CTF/Chemistry, Pharmacy, Biology

Laurea Magistrale in Regulatory Affairs

Descrizione del lavoro

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BSP Pharmaceuticals S.p. A is focused on the development and manufacturing of anticancer drugs with high potency and cytotoxitc characteristics for the Pharmaceuticals Industry.

BSP has been at the forefront in the fight agains cancer since 2006.

Innovation is the hallmark of BSP with investments in new technologies and production methods in a high containment plant.

We are one of the most important Contract Development and Manufacturing Organization (CDMOs) for anticancer drugs.

The fight against cancer is ours too.

We are currently looking for a Regulatory Affairs Specialist

Main activities :

• Support the monitoring of the site's regulatory compliance through the implementation, management and control of the necessary GMP documentation both internal and provided by clients and suppliers;
• Implement and manage regulatory document storage databases;
• Manage technical documentation related to adventitious agents (TSE, Viral Clearance, Allergens, Aflatoxins, GMOs, latex, gluten, conflict materials etc.);
• Support clients in the registration and post-registration phases through the preparation of dossiers (also in eCTD format);
• Manage consular paperwork for international registrations, coordinating the various external entities (notary, public prosecutor's office, prefecture, consulates and consultants) to issue the appropriate legalized documentation;
• Support the management of the MIA maintenance practices for the medicines production, preparing the paperwork for variations, communications, authorization/registration for the import of active substances or updating the Site Master File;
• Process and manage the DMF for the active substances production for commercial use.

Main requirements:

• MA degree (CTF/Chemistry, Pharmacy, Biology..);
• MS degree in Regulatory Affairs is considered a plus;
• 5 years of experience in similar roles in complex organizations;
• Knowledge of GMP;
• English working knowledge;

At BSP we believe in an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential. We respect the diversity , the different backgrounds and experiences and provide equal opportunity for all.