Contractor Regulatory Manager 12 mesi ROMA

Randstad Italy; Roma; Ibrido; EUR 40.000 - 50.000; Tempo pieno

Descrizione del lavoro

Un'importante azienda farmaceutica sta cercando un Contractor Regulatory Manager per il team di regolamentazione a Roma. Il candidato ideale ha un Master e almeno 8 anni di esperienza nel settore GXP. La posizione prevede lavoro ibrido con un contratto a tempo determinato di 12 mesi, retribuzione compresa tra 40.000€ e 50.000€. È richiesto un forte approccio alla gestione dei progetti e alle comunicazioni efficaci.

Competenze

• Minimo 8 anni di esperienza nel settore GXP o in ruoli di Regulatory Affairs.
• Almeno 4 anni di esperienza in Product Quality Assurance in un ambiente GMP.
• Comando della lingua inglese e conoscenze multilingue sono un vantaggio.

Mansioni

• Iniziare, esaminare e approvare modifiche regolatorie tramite il sistema enterprise di Pfizer.
• Fornire supporto per la chiusura delle lettere di carenza e richieste di autorizzazione.
• Punto di contatto principale per le attività regolatorie dei contractor gestiti da ESOQ.

Conoscenze

Negoziazione

Competenze comunicative

Gestione progetti complessi

Competenze informatiche avanzate

Formazione

Master in Scienze, Ingegneria o discipline correlate

Strumenti

MS Office

Documentum

Descrizione del lavoro

Overview

Randstad Inhouse Services, specialty Pharma, is looking for a resource on behalf of Pfizer srl to join the regulatory team as Contractor Regulatory Manager.

Expected placement at the Rome office with initial fixed-term contract (12 months). Position according to the chemical collective bargaining agreement commensurate with experience.

Hybrid work expected

Retribuzione annua : 40000€ - 50000€

esperienza

da 6 a 10 anni

Basic qualifications :

• Master’s degree in Science, Engineering, Pharmaceutical Sciences or related technical discipline
• Min. 8 years of experience in GXP setting and / or Regulatory Affairs role
• At least 4 years of Product Quality Assurance experience in a GMP environment
• Advanced in computer skills such as MS Office applications and good knowledge of enterprise systems such as PDM, QTS Trackwise, Documentum platforms
• Good command of English language and multi-lingual is a benefit
• Shows strong negotiation skills and is diplomatic in communication with internal and external customers
• Strong verbal and written communication including presentation skills
• Demonstrated personal leadership to manage cross functional project
• Demonstrated experience managing complex quality and compliance activities in a manufacturing plant or with a contractor
• Able to report remotely and deliver work independently

Preferred Qualifications :

• Willing to lead by example and jump right in, desire to get to root cause, collaborative and active listener
• Effectively manages stressful situations, able to focus on task at regardless of circumstances and stress induced pressure
• Supervisory experience desirable
• Up to 10% travel if required
• Has a broad GMP and technical know-how to handle emerging issues
• Developing ability to resolve conflicts

La ricerca è rivolta ai candidati ambosessi (L.903 / 77). Ti preghiamo di leggere l'informativa sulla privacy Randstad (https://www.randstad.it/privacy/) ai sensi dell'art. 13 del Regolamento (UE) 2016 / 679 sulla protezione dei dati (GDPR).

Primary Responsibilities

• Initiate, review and approve regulatory changes through Pfizer enterprise system (i.e PDM) for changes initiated by or impacting ESOQ managed contractors.
• Provide support for the closure of the deficiency letters, CMC Commitments, Regulatory requests for Renewals, New Product registrations and Post approval variations.
• Main point of contact for Global ChemistryManufacturing & Controls (GCMC) dpt or Local Regulatory Affairs in Pfizer Country Offices for the regulatory activities involving the ESOQ contractors.
• As the Regulatory Expert, participate in Virtual Site Operating Teams (VSOT) or similar meeting for ESOQ managed contractors and if needed, participate in Site Quality visits at the contractors.
• Support and Perform Lot Disposition for Biotech semi finished and finished products (if applicable).