lavori da Farmaceutica in località Italia

Descrizione del lavoro

A global pharmaceutical company is seeking a dedicated Regulatory Affairs Labelling professional to join their team. This role involves supporting global labelling teams, ensuring regulatory compliance, and managing product labelling across various regions. The position offers flexibility to work from home or office in multiple European locations. Candidates should possess a university degree in a scientific discipline and regulatory experience, along with strong communication skills and problem-solving abilities.

Competenze

• Initial years of labelling / regulatory experience with global responsibilities.
• Outstanding interpersonal and intercultural communication skills.
• Critical thinking and problem-solving abilities.

Mansioni

• Support Global Labelling and Regulatory teams for updates.
• Manage Company Core Datasheet implementation into labelling.
• Identify triggers for updates and coordinate impact assessments.
• Apply knowledge of Safety Signal Management on labelling.
• Navigate CCDS governance processes in pharmaceutical environments.
• Understand Periodic Safety Update Reports and their impact.
• Manage the relationship between labelling and artwork processes.
• Implement regulatory processes for product labelling updates.
• Prepare Addendum to Clinical Overview for labelling variations.
• Apply regulatory requirements for updates across different regions.
• Manage SmPC, PIL and QRD requirements and translation activities.
• Coordinate readability and PIL testing processes.
• Review and approve consumer-facing materials.
• Participate in promotion review committees and provide guidance.
• Provide technical and business consulting services.
• Complete activities within project scope, timeline, and objectives.