Global Core Labelling Strategy Lead

Viatris

Dublin

On-site

EUR 90,000 - 130,000

Full time

14 days+

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Benefits offered by this job

Excellent career progression

Health insurance

Pension

Diversity & Inclusion

Job summary

Viatris is seeking a Regulatory Labelling Lead to provide global expertise in developing, maintaining and implementing Product Information in line with regulatory requirements. The role drives CCDS, TPL and EU/US labelling with cross-functional partners to align with corporate strategy.

The successful candidate will lead labelling strategy, coordinate submissions, and ensure scientific accuracy and regulatory acceptability across regions, contributing to lifecycle management and proactive

Qualifications

Bachelor’s degree (or equivalent) in Science, Medicine, Pharmacy, or related field.
Significant labelling experience with global core labelling (e.g. CCDS) and major market labelling (e.g. USPI, EU SmPC).
Experience supporting regulatory submissions (e.g. NDA/BLA/MAA).
Advanced degree (MSc, PharmD, PhD) advantageous but not required.

Responsibilities

Provide global regulatory labelling expertise and leadership for Product Information development and maintenance.
Manage and deliver labelling activities across assigned products/portfolio.
Lead development, review, and approval of global labelling docs (TPL, CCDS, Core Patient Information).
Develop and maintain Target Product Labelling (TPL) to support early development and regulatory positioning.
Establish cross-functional partnerships with Regulatory, Medical, Safety, and Clinical teams.