26 ago
|
Jefferson Wells Italia
|
Abruzzo
26 ago
Jefferson Wells Italia
Abruzzo
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
▪ 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.215/200
📌 Site Regulatory Affairs Associate (Abruzzo)
🏢 Jefferson Wells Italia
📍 Abruzzo