Site Regulatory Affairs Associate

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7knhre

SITE REGULATORY AFFAIRS ASSOCIATE

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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

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- 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

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- 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
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 (Manp

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7knhre