Senior EU Labelling & Regulatory Strategy Lead

Michael Page

Lisboa

On-site

EUR 90,000 - 130,000

Full time

5 days ago

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Job summary

Michael Page client in Lisbon is seeking a senior Regulatory Labelling Lead to oversee European labelling activities for generic and branded products. You will ensure regulatory compliance, drive operational excellence, and implement timely labelling updates across the product lifecycle.

You will coach a high-performing labelling team, provide strategic guidance on EU requirements (SmPC, PIL, CCDS), and partner with Regulatory Affairs, Quality, Supply Chain and Legal to deliver end-to-end

Qualifications

Minimum 5 years in product labelling or regulatory affairs in pharma/healthcare.
Proven leadership of cross-functional teams in matrix organisations.
Deep knowledge of EU labelling regulations (SmPC, PIL, CCDS) and product lifecycle.
Strong stakeholder management and project leadership skills.
Experience with Lorenz and TrackWise and document management platforms is advantageous.

Responsibilities

Lead regional labelling activities across Europe for generic and branded products.
Ensure regulatory compliance and timely implementation of labelling updates.
Coach and develop a high-performing labelling team with clear objectives.
Provide strategic regulatory leadership on EU requirements and CCDS assessments.
Collaborate with Regulatory Affairs, Medical Affairs, Quality, Supply Chain, Launch Management and Legal.
Drive continuous improvement and support audits and inspections.