Site Regulatory Affairs Associate
3 settimane fa
Abruzzi, 65, Italia
Jefferson Wells Italia
Tempo pieno
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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 ▪ 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.*
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.*
