Regulatory Labelling Specialist

Advanced Resource Managers; Venezia; In loco; EUR 45.000 - 60.000; Tempo pieno

Descrizione del lavoro

A growing consultancy in Italy is seeking a Regulatory Labelling Specialist to manage labeling processes and ensure regulatory compliance. The ideal candidate will have over 3 years of experience in the pharma industry, particularly with generics. Responsibilities include overseeing labeling reviews, supporting document creation, and collaborating with medical teams. Excellent communication and familiarity with labeling guidelines are essential. This role provides a great opportunity for professionals looking to enhance their expertise.

Competenze

• 3+ years of labeling experience within the pharma industry.
• Understanding of labeling changes and guidelines.
• Experience in documentation and archiving.

Mansioni

• Manage the labeling review and approval processes.
• Support the creation and maintenance of regulatory documents.
• Work closely with the Medical Affairs team for guidance.

Conoscenze

Labeling experience

Regulatory compliance knowledge

Communication skills

Formazione

Degree qualification

Strumenti

DocuBridge

drugTrack

Descrizione del lavoro

Advanced Resource Managers are currently searching for a Regulatory Labelling Specialist for one of our clients, a small but growing consultancy.

You will be involved with the following responsibilities within the role:

1. Manage the labeling review and approval processes.
2. Support the creation and maintenance of regulatory compliant documents.
3. Work closely with the Medical Affairs team to provide medical relevance assessment and labeling guidance.
4. Conduct text comparisons (originator, reference vs generic).
5. Document and monitor all global and local changes for the assigned portfolio of brands/products.
6. Contribute to labeling process improvement initiatives.

Skills / Experience needed

• Degree qualification.
• 3+ years of labeling experience within the pharma industry (generics) or experience in regulatory affairs.
• Understanding of labeling changes.
• Solid knowledge of labeling guidelines and regulations.
• Experience in documentation and archiving.
• Experience with DocuBridge and drugTrack is an advantage.
• Team player with good communication skills.

If you are interested in this opportunity, please contact Vik Patel at ARM.