Regulatory Affairs Specialist: EU & Italy Lifecycle

Alfasigma; Pomezia; In loco; EUR 40.000 - 56.000; Tempo pieno

Vantaggi offerti da questo lavoro

Comprehensive benefits

Career growth opportunities

Descrizione del lavoro

Alfasigma is seeking a Regulatory Affairs Specialist to support local Italian product regulatory strategies, including new MA and lifecycle management. You will prepare dossiers, interact with AIFA, and ensure compliant submissions for local and global brands.

You will collaborate with Quality, Medical Affairs, Market Access, and cross-functional teams, leveraging digital tools to improve efficiency and data integrity. Fluency in English and strong regulatory knowledge are essential.

Competenze

• 2+ years regulatory affairs experience in pharma with focus on Italian and EU guidelines.
• Degree in Pharmacy and Pharmaceutical Chemistry and Technology (CTF) or in Pharmacy, Pharmaceutical Chemistry and Technology, or related life-science.
• Master's Degree in Regulatory Affairs is a plus.
• Good knowledge of registration procedures and dossier preparation for EU and Italy.
• Fluency in English, both written and spoken.

Mansioni

• Manage regulatory activities for assigned Rx and OTC products across their lifecycle, ensuring compliance with Italian and EU requirements.
• Prepare, review and submit regulatory dossiers, including variations, renewals, and MA maintenance.
• Interact with Italian regulatory bodies (AIFA) and other authorities under supervision.
• Support development and approval of promotional materials per regulations and company standards.
• Collaborate with cross-functional and international teams to manage a portfolio of ~10 products.
• Monitor regulatory changes and propose actions to adapt portfolio.
• Leverage digital tools to improve regulatory processes and data integrity.
• Maintain accurate regulatory documentation and ensure audit readiness.
• Contribute to continuous improvement and digital innovation within Regulatory Affairs Italy.

Conoscenze

Regulatory affairs

English fluency

MS Office

Cross-functional collaboration

Attention to detail

Project management

Communication skills

Formazione

Pharmacy degree (CTF)

Regulatory affairs master (plus)

Strumenti

eCTD publishing

Veeva RIM

Document management systems

Descrizione del lavoro

Alfasigma is seeking a Regulatory Affairs Specialist to support local Italian product regulatory strategies, including new MA and lifecycle management. You will prepare dossiers, interact with AIFA, and ensure compliant submissions for local and global brands.

You will collaborate with Quality, Medical Affairs, Market Access, and cross-functional teams, leveraging digital tools to improve efficiency and data integrity. Fluency in English and strong regulatory knowledge are essential.