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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