Site Regulatory Affairs Associate

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

Smart working: 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 lavoro a tutt* i/le candidat* e sono impegnate nel favorire il rispetto delle diversità e l’inclusione sul posto di lavoro, in linea con i principi di trasparenza e parità retributiva.