Regulatory Affairs Professional - Labelling (home or office based)

Parexel; Italia; Ibrido; EUR 45.000 - 65.000; Tempo pieno

Descrizione del lavoro

A leading pharmaceutical consulting company is seeking a Regulatory Affairs Labelling professional in Italy. This role offers the flexibility of home or office work and involves managing global labelling compliance and product labelling management across regions. Key responsibilities include collaborating with international teams, coordinating labelling updates, and regulatory processes. The ideal candidate has a scientific background, labelling experience, and excellent communication skills in English. An opportunity to shape product information and contribute to compliance in the pharmaceutical industry awaits.

Competenze

• Initial years of labelling / regulatory experience with global responsibilities.
• Outstanding interpersonal and intercultural communication skills (written and verbal).

Mansioni

• Support Global Labelling, Regulatory, or Medical Writing teams for labelling updates.
• Manage Company Core Datasheet (CCDS) implementation into labelling and artworks.
• Apply regulatory requirements for labelling updates across different regions.

Conoscenze

Regulatory Operations (Submission management)

Interpersonal communication

Critical thinking

Problem-solving

Fluent in English

Formazione

University Degree in a Scientific or Technical Discipline

Descrizione del lavoro

When our values align, there's no limit to what we can achieve.

We are seeking a dedicated Regulatory Affairs Labelling professional to join our growing team! This role offers an opportunity to work with global labelling teams, ensuring regulatory compliance and supporting product labelling management across multiple regions.

The role can be home or office based in various European locations.

Role Responsibilities

• Support Global Labelling, Regulatory (Clinical / Safety), or Medical Writing teams for labelling updates
• Manage Company Core Datasheet (CCDS) implementation into labelling and artworks
• Identify triggers for CCDS updates and coordinate impact assessments for technical changes
• Apply knowledge of Safety Signal Management and its impact on labelling
• Navigate CCDS governance processes in pharmaceutical environments
• Understand Periodic Safety Update Reports (PSUR) and their potential impact on labelling
• Manage the relationship between labelling and artwork processes
• Implement regulatory processes required to update product labelling (various variation categories)
• Prepare Addendum to Clinical Overview (Module 2.5) to support labelling variations
• Apply regulatory requirements for labelling updates across different regions (EU, EAEU, US, APAC)
• Manage SmPC, PIL and QRD requirements, EU linguistic reviews, and translation activities
• Coordinate readability and PIL testing processes
• Review and approve consumer-facing materials in accordance with approved labelling
• Participate in promotion review committees and provide regulatory guidance for local markets
• Provide technical and business consulting services within area of expertise
• Complete activities within project scope, timeline, and objectives

Skills and Experience required for the role

• University Degree in a Scientific or Technical Discipline
• Initial years of labelling / regulatory experience with global responsibilities
• Regulatory Operations (Submission management) experience
• Outstanding interpersonal and intercultural communication skills (written and verbal)
• Critical thinking and problem-solving abilities
• Fluent in English, written and spoken