Technical Regulatory Associate

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/8ih6qk

Johnson & Johnson seeks a Technical Regulatory Associate for its Latina manufacturing site to manage change control requests, ensure regulatory compliance with GMP standards, and coordinate international registration documentation for pharmaceutical products.
Responsibilities
Evaluate, coordinate, approve, and close local and international change requests from quality assurance perspective
Review completeness and accuracy of change request activity plans and ensure timely execution
Assess and approve change requests at committee level for quality, safety, and efficacy impact
Coordinate with international functions and external sites on change management




Prepare international and local registration documentation collaborating with regulatory affairs departments
Requirements
Master's degree in pharmaceutical chemistry, pharmacy, chemistry, or biology
1–3 years quality assurance experience in regulated pharmaceutical environments
Knowledge of GMP guidelines and regulatory requirements
Experience managing production documentation and change control processes
Proficiency with quality management systems such as SAP
Strong analytical skills, attention to detail, and problem-solving ability
Fluent English and proficient with Microsoft Office

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/8ih6qk