Global Regulatory Affairs Associate

Recordati; Turbigo; In loco; EUR 32.400 - 39.600; Tempo pieno

Descrizione del lavoro

Recordati is seeking a Regulatory Affairs Associate on a fixed-term contract to join the International Corporate Regulatory Affairs team in Italy. You will manage regulatory activities for SPC medicinal products for human use, including EU marketing authorisations and non-EU submissions.

Responsibilities include preparing and submitting regulatory documentation, coordinating with cross-functional teams, maintaining core dossiers, and monitoring legislation to ensure compliance.

Competenze

• At least 6 months to 1 year of experience in Regulatory Affairs in multinational pharma.
• In-depth knowledge of pharmaceutical legislation for human use.
• Experience with electronic systems for regulatory documents management.

Mansioni

• Prepare, review and submit regulatory documentation to Health Authorities.
• Manage regulatory data in electronic systems and support submissions.
• Define regulatory activity plans and timelines with cross-functional teams.
• Coordinate with affiliates, licensees and consultants on regulatory activities.
• Monitor legislation and ensure regulatory compliance across markets.
• Provide regulatory assessment for new business opportunities.

Conoscenze

Regulatory knowledge

Documentation management

Communication skills

Time management

Formazione

Scientific Degree

Master in Regulatory Affairs (preferred)

Strumenti

RIMS

DMS

eCTD platform

Descrizione del lavoro

Recordati is seeking a Regulatory Affairs Associate on a fixed-term contract to join the International Corporate Regulatory Affairs team in Italy. You will manage regulatory activities for SPC medicinal products for human use, including EU marketing authorisations and non-EU submissions.

Responsibilities include preparing and submitting regulatory documentation, coordinating with cross-functional teams, maintaining core dossiers, and monitoring legislation to ensure compliance.