Rome-Based Local Regulatory Associate (Sponsor-Dedicated)

Syneos Health, Inc.; Roma; In loco; EUR 31.500 - 38.500; Tempo pieno

Descrizione del lavoro

Syneos Health is seeking a Sponsor Dedicated Local Regulatory Associate based in Rome to provide Italian/EU regulatory expertise for a portfolio of rare disease products. The role requires attendance at the Sponsor's offices in Rome and collaboration with internal teams to ensure compliance with local requirements.

The ideal candidate will have 2–4 years of regulatory affairs experience, strong communication skills in Italian and English, and familiarity with local authorities and regulatory

Competenze

• Experience across the drug development life-cycle (development and post-authorization).
• Regulatory affairs experience (2–4 years) and knowledge of local/regional requirements.
• Ability to interact with Regulatory Authorities and internal/external stakeholders.

Mansioni

• Provide local regulatory expertise and handle local submissions for a single Sponsor.
• Prepare local labeling documentation and review Advertising/Promotional Material.
• Interact with AIFA and other departments to ensure regulatory compliance; Italian native speaker required.

Conoscenze

Regulatory knowledge

Communication

Project management

Cross-functional collaboration

Teamwork

Formazione

Biological sciences degree

Strumenti

Veeva RIM

Descrizione del lavoro

Syneos Health is seeking a Sponsor Dedicated Local Regulatory Associate based in Rome to provide Italian/EU regulatory expertise for a portfolio of rare disease products. The role requires attendance at the Sponsor's offices in Rome and collaboration with internal teams to ensure compliance with local requirements.

The ideal candidate will have 2–4 years of regulatory affairs experience, strong communication skills in Italian and English, and familiarity with local authorities and regulatory