Rome-Based Local Regulatory Associate — Sponsor

Syneos Health; Milano; In loco; EUR 31.500 - 38.500; Tempo pieno

Descrizione del lavoro

Syneos Health in Rome seeks a Local Regulatory Associate to provide regulatory expertise for a portfolio of products, working closely with the Sponsor’s local team and interfacing with national authorities. The role requires attendance at Sponsor offices in Rome and fluency in Italian.

The ideal candidate has 2–4 years in regulatory affairs, experience with local labeling, and strong communication in Italian and English. CCNL applicability and local procedures govern employment.

Competenze

• Experience across the drug development life-cycle (development and post-authorization).
• 2–4 years in regulatory affairs and understanding of local/regional requirements.
• Experience negotiating with Regulatory Authorities.
• Ability to interact with International Regulatory Affairs colleagues, other departments within the Company and external parties (national authorities, trade associations, professional bodies, etc.).
• Ability to assess complex scientific information, regulatory precedent, competitive intelligence, and regulatory guidelines and make recommendations based on assessment.
• Experience with Veeva RIM module.
• Strong problem-solving skills and ability to work in cross-functional teams.
• Ability to plan, prioritize, and execute work.
• Italian mother tongue; strong written and verbal communication in Italian and English.

Mansioni

• The Local Regulatory Associate will work dedicated to a single Sponsor. Attendance to the Sponsor's offices in Rome will be required.
• Provide local regulatory support, including local submissions and regulatory insight.
• Prepare local labeling documentation and review Advertising and Promotional Material.
• Interact with AIFA and with other company departments and external bodies as required.

Conoscenze

Regulatory affairs

Cross-functional teamwork

Communication skills

English proficiency

Italian

Strumenti

Veeva RIM

Descrizione del lavoro

Syneos Health in Rome seeks a Local Regulatory Associate to provide regulatory expertise for a portfolio of products, working closely with the Sponsor’s local team and interfacing with national authorities. The role requires attendance at Sponsor offices in Rome and fluency in Italian.

The ideal candidate has 2–4 years in regulatory affairs, experience with local labeling, and strong communication in Italian and English. CCNL applicability and local procedures govern employment.