18 set - Italia
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SITE REGULATORY AFFAIRS ASSOCIATE
Location: Abruzzo
Jefferson Wells, on behalf of a leading Italian pharmaceutical company, is seeking a Site Regulatory Affairs Associate .
Reporting to the Quality Unit Manager, the successful candidate will be responsible for managing site Regulatory Affairs activities, ensuring regulatory compliance and supporting Quality System processes within a pharmaceutical manufacturing environment.
Key Responsibilities
Manage site regulatory compliance activities and related documentation.
Prepare and maintain technical documentation for regulatory submissions and registrations.
Support Change Controls and deviations with regulatory impact.
Ensure regulatory assessment of manufacturing and quality-related changes.
Participate in internal and external audits, including inspections by regulatory authorities.
Support Quality System activities, CAPA monitoring and continuous improvement initiatives.
Requirements
Degree in Pharmacy, CTF, Chemistry or related scientific disciplines.
Minimum 3 years of experience in Regulatory Affairs within a pharmaceutical manufacturing environment.
Experience managing regulatory aspects of Change Controls and Deviations.
Strong knowledge of Quality Systems and pharmaceutical regulatory requirements.
Experience supporting regulatory audits and inspections.
Fluent English (minimum B2 level).
The ideal candidate combines strong analytical skills, attention to detail, effective communication abilities and a continuous improvement mindset.
Compensation Package
Contratto a tempo indeterminato e assunzione diretta
CCNL Chimico farmaceutico
Livello di inquadramento: C
RAL 35.000 € - 40.000 €
Premio partecipazione, mensa, welfare
Lavoro da remoto: 2 giorni a settimana
Questa opportunità è gestita da Jefferson Wells Italia (ManpowerGroup), che supporta l'azienda cliente nel processo di selezione. ManpowerGroup in Italia garantisce (ai sensi del D.Lgs 198/2006, D.Lgs.215/2003 e D.Lgs.216/2003) pari opportunità di accesso al
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